Evaluating Your Laboratory’s Risk Management Process or Quality Improvement Process

Please be sure to keep the caption window open if you use it and also keep the Zoom meeting open. If you have questions throughout today's events, please include those in the questions and answers function at the bottom of your Zoom panel. We'll answer the questions at the end of each session. And I'll now turn it over to Alicia Branch, our OneLab Network lead, to introduce our next speakers, Alicia.

Thank you, Blanche. I'm thrilled to introduce this dynamic duo. First, Commander Sabrina DeBose. Sabrina is a team lead for the biosafety Core team in the Quality and Safety Systems Branch, or QSSB, and the Division of Laboratory Systems here at CDC. She has combined experience in biorisk management, regulatory compliance, emergency preparedness, and program management.

As team lead, Commander DeBose provides technical expertise and guidance in bio-risk management and clinical expertise to bio-risk management to clinical and public health laboratories. She is responsible for delivering high-level oversight and coordinating clinical laboratory policies and operations associated with laboratory safety.

Dr. Diego Arambulu is a Quality Team Lead for the Quality and Safety Systems Branch in the Division of Laboratory Systems here at CDC. He leads the Next-Generation Sequence Quality Initiative, a collaboration between CDC, APHL, and partner state and local public health laboratories to develop, develop a sequencing-specific quality management system. Diego works to improve the quality of laboratory testing in clinical and public health laboratory settings, focusing on quality management for molecular assays. 

Our next speakers are Dr. — are Dr. Diego Arambula and Commander Sabrina DeBose. 

So I just want to thank the conveners and for giving Sabrina and I an opportunity to present on both the quality management quality practices, as well as risk management in laboratories. I do want to call out that Sabrina is in the Division of Laboratory Systems and is now our acting deputy branch chief, thus speaking further to her ability to provide guidance and insights. 

So I want to briefly touch on the Division of Laboratory Systems, which is the — the first center at CDC to focus on laboratories and laboratory systems. So DLS works to improve laboratories in both public health and clinical settings and the systems that support laboratories throughout the whole testing cycle.

It works to improve, not only clinical care and public health, but has activities touching emergency response and a number of activities regarding health equity and the utilization of laboratory systems to — for the improvement of health equity,

I just want to highlight what we're going to go over today. I'll start over with quality management systems, quality practices. Then Sabrina — Commander DeBose will go ahead and take over and talk about the intersection between quality and risk management, and then delve further into risk management assessments, and close us out.

So I had a, an advisor who kind of loved to pontificate on their role for spewing copious amounts of information, then hopefully within were the nuggets of knowledge that everybody could use. So I will absolutely adopt that, in that I don't think anyone on this call is unfamiliar with quality and quality practices, particularly in a laboratory setting. Hopefully in this overview and kind of bits of deep diving, there will be a nugget of knowledge that everyone can take.

So while perhaps this sounds formidable, but this concept of, what is quality? What does it mean to everybody, and the — the diversity of what it means? Now, according to the American Society for Quality, it's a subjective term. And each person or sector has its own definition.

So, for example, the quality in your laboratory might mean that test results, you're focusing on the test results, they're accurate, accurate, reliable, timely. Furthermore, it could also mean that your laboratory products and services are in compliance with specifications, regulations, and ultimately meet customer needs, whoever those customers might be, and expectations. So there is no one approach to quality, right? 

And it's not a formula. And I say that purposely, because when we start talking about quality policies, quality practices, buy-in on an institutional level, it matters what it needs to be and what quality means and, and that ability to garner buy-in in matters. And so again laboratories, we see without question, need to produce dependable testing, accurate results that are reproducible, repeatable in a timely manner, always with this, the specter of limited resources, right?

I think it would be absolutely great, although, perhaps a bit of a fantasy, if every laboratory had all the staffing and funding that it requires. So I think this ability to be cognizant of what we use our resources on, is a very real thing. 

Because the complexity — and I think some would argue — that the ever increasing complexity of laboratory testing, requires more of this systematic approach to ensure not only the accuracy but the reliability of and increasingly, the utility of those test results on end services.

So controls and assurance of quality should extend beyond individual metrics. You know accuracy and control is absolutely required, but should not be — and I don't think common practice — is the end all. So a quality management system, what we're going to be approaching here, is that systematic approach to describing, documenting, implementing continual improvement, that measuring and then that monitoring, that testing, monitoring of operations.

Our processes and procedures are purposely designed and guided by continual improvement. Or is this idea of how do we make it better, how to respond, not only to emergencies, but to ever changing climates, supply chains, for example. 

They do need to meet and be customized towards institutional situations, regulations but also other regulatory or accreditation requirements. Ensuring quality in laboratories requires a process-driven and systematic approach to manage all laboratory activities, and we'll get into what all those activities perhaps might mean. And then this plan and systematic approach helps to ensure that laboratory results are accurate and reproducible.

And then quality management is used to actively manage again all those activities and to the extent possible, organizational or related organizational functions, facilities, for example; purchasing. And we will build on — sometimes there's instances where things should not be managed, and then how those impact the laboratory system as a whole. 

Again, I don't think this is — the slide is a surprising at all, and I'm not going to go through it in its entirety. But really, I just want to focus on this evolution, this natural evolution, I think, that has occurred, where we look at quality control of a particular method. Method validations really come to mind.

But we move up from methods, modalities really, to more of processes, how laboratories are form and function, to also then that ever increasing laboratory system. All those interacting — again tests don't run, even increasing automation, tests don't run themselves yet. And so those personnel, those competencies always with consideration. And then as was mentioned earlier today and I'm sure in previous days, there was retention and training and then buy-in and specialization of the personnel performing these tests.

Oftentimes quality control — and not always — but there's some limitations at to, in the total testing process from receipt, accessioning to resulting. What are they controlling for? You know the reality of the situation is, you know, quality control metrics are required, but often times it can be challenging to control for every iteration and every step.

So as we move towards that assessing of processes, we started getting to those pre- and post- analytical errors. But then again, as we move from control to assurance to management, we then, again, start taking that step back and looking at those systematic and wide focus that's broader than assurance, that's broader than quality controls, and to look at the processes themselves from end to end. But also how those processes integrate into that other laboratory functions. And then, again, how do those laboratory functions integrate into public health laboratories, into clinical laboratories, in the hospital systems?

So this is, I — I think, we're going to go ahead and open the Q&A. But regardless, this is I think just of a pre- and post- situation. What is your perceived status of quality practices in the laboratory? We've talked about quality controls for particular method or modality.

And we take that higher step into the assurance of the end-to-end processes to really look that they're fully developed, monitored, and are effective when we start thinking about noncompliance. But then again, that — is your laboratory already there? That the quality management system is complete. It's set up, it considers all these aspects. It has buy-ins from key partners at all levels, whether that's a director or the laboratory — of the institution or of the laboratory. 

Or it's just, I always like to inject a little bit of levity you know — what is it, what is quality? So when we start thinking about that again, that's quality management systems, we've already been talking about it. There's this idea of — oh, perhaps I just went ahead too fast. 

Maybe I'll, I'll just pause because I see that the poll results are coming in. But as you're going through this and completing that, that poll, when we start talking about quality control and quality assurance, sees ever increasing overlap in concentric circles. 

We really think about a quality management system as formalized, agreed upon, and documented. 

Everything we do has to be documented. But again are all the peripherals documented as well, and all aspects of operation? And you know, Sabrina will speak to this more. Then things like risk assessments really start to come into mind as to what is the assessment, what are the potential break points, what are the failure points, is it middleware, right? Are we having an issue with middleware? We can't transmute information.

Is it more so than onboarding new analysts, what are the opportunities there? And it's just that. It's when we look at a systematic approach, it's these opportunities to identify improvements and then implement those changes effectively so that the personnel performing the test and then over approving the test and then those approving the, I'm sorry, perhaps directing the facility all have buy-in and agreement. 

So when we talk about actively managing all laboratory activities, that is to the extent possible because there are, of course, limitations, organizational limitations, fiduciary limitations. But we do recognize that the laboratory science, and therefore the systems, are then impacted.

And we always have to say — and it is extremely unlikely that many aspects of this aren't already normal practices in the facilities and all laboratories. I think it would be shocking if there was a laboratory running an assay without quality control metrics. But again, it's that also this concept of continual improvement, the ability to garner feedback and then improve, not only how that assay is performing. 

But when we think about it, I think we've all run into situations where, for example, if you're resulting out in 48 to 72 hours for your tests, but your customer is walking out the door in 24 or the opportunity to impact or that utility ends after 24 hours. The test is operating fine. There's nothing wrong with the test, per se, in its performance. However, that utility then perhaps isn't there, and is there opportunity for improvement? 

So QMS is distinct from I think obviously, you know, quality control and quality assurance. Quality control with that effort to detect and correct errors or defects in services, as well as assurance that proactive processes, that are focusing on prevention of error or defects.

Now, when implementing a quality management system, it ensures that quality management functions — again, fully integrated with the technical and administrative options of the laboratories. So that helps in, you know, having a structured system that documents all the processes, all the procedures, and notably, all the responsibilities.

This goes beyond testing personnel, right. I think testing personnel are always in the forefront of our minds but impacts or limitations can come from nontesting personnel. Again, administrative considerations. And so we help to meet the requirements of quality policies and objectives that should be documented and established by the laboratories. Then there's coordinating and controlling organizational activities. 

What are the services that are going to be offered? Perhaps depending on the population, what services shouldn't be offered? Is everything in house, are things — should be, are we going to start doing send out or distributed models? Obviously, this code of, level of consideration and coordination helps with regulatory compliance, both internal and external assessments of note. 

And again, whomever those customers might be — the epidemiologists, the clinicians, other laboratories, the CDC — satisfying their requirements and their results and continually improving to enhance operational effectiveness and efficiency. 

So quite a few benefits, and I won't go through them all. But I do want to highlight a few because I think recent activities really brought fore and front a couple aspects. Scientific excellence. For public health research, clinical laboratories need to uphold a reputation for providing medical and scientific excellence. I'm sorry, excellence.

The implementation of a QMS certainly helps laboratories maintain positive scientific reputation and ensures that the laboratory science being conducted and resulted has the highest standard of quality and safety for the practitioner. Customer satisfaction and the improvement of customer satisfaction. Now quality management does ensure that laboratory patients and customers are satisfied and their requirements are consistently being met. Gaining the patients' and customers' confidence and satisfaction is a great achievement and it helps enhance the overall reputation of the laboratory.

Operational efficiency of management system increases operational efficiency by improving the use of time and, again, those key resources are used by the laboratory. You can connect processes and procedures and then in such, laboratories are able to turn out planned activities into results. Quicker onboarding is an aspect that comes into mind, expanding of analytes, another aspect that comes in the models. Reduced review time is something we hear constantly and that ability to reduce that burden. Overall, over time these processes and procedures are refined until the laboratory is a system that is effective, efficient, and consistently producing high-quality results. 

Again, this idea of continual improvement. Laboratories can demonstrate a commitment to quality by focusing on continual improvement, and this process helps to streamline workflows as well as empowers personnel at all levels. Again daily practitioners, the testing personnel all the way through to directors to identify opportunities for improvement. 

And one absolute aspect is that lowering of costs and reducing of waste. So quality management systems are there to, when functioning effectively, cut costs, reduce waste, and decrease the amount of time personnel spend on correcting errors, defects, and reporting of that. Early detection and resolution of issues helps reduce processing and testing errors and decreases the likelihood of releasing of poor quality or incorrect resulting to the customers. 

And I do want to highlight this. Again, I don't think that this is surprising. Well but there is an absolute cost — and I think it is well published, well recognized — to quality and that is, some of the benefits we talk about, about the good quality, but also poor quality, as well. 

And I won't go through all of them, but I think we're all aware of reporting errors, of the potential for mixed diagnoses, unsatisfied customers, the inability to have a useful result in a timely fashion. These do have reputational costs, and so these are just external aspects of poor quality.

Internal aspects of poor quality also could come from mislabeled specimens, data entry errors, having to test and retest. And then additional time and money spent in analyses of failures and nonconforming events. When we then turn towards good quality, I think it then becomes immediately more appreciable that when we do go through things like the planning and the training, preventive maintenance. Apologies. These then lend themselves naturally to internal audits, external audits, inspections. 

And then the assistance with the competency assessments. There's absolutely, I think without question, the recognition of what this cost is. And so across the board, there's opportunities for facilities at every level for improvement.

So it's been very, very, I think, high level. But what we do want to leave with is some operationalizations. So there is many opportunities to improve quality and this has been published on. What we want to do, is just highlight on a couple of emerging concepts. And that is that there's the opportunity to use, for example, you know Clinical Laboratory Standards Institutes, they have a framework based — of a quality management system based on their 12 QSEs [quality system essentials]. 

There's American Society for Quality. They also have a framework, you know — appreciable — and there's parity. And that's what I think what we're trying to get across here, is whether it's 12 QSEs organized in terms of the resources, the work, and then the evaluation, the QA and the improvement. 

We see quite a bit of parity when we think about quality manuals. That speaks to not only many aspects of laboratory resources; there were procedures and instruments in process management. So we can start to see that there are fundamental approaches to how a quality management should operate.

But there's also the ability for the institution — it's not just this cookie cutter situation anymore. We have to take, say, "Oh, I have to go absolutely conform to all these elements." There's opportunities to customize it for laboratory implementation.

So laboratories need to consider the standards that — whether that's CLSI, whether that's an accrediting organization or similar — that meets their objectives, one that meets their needs, encompasses the services that they want to provide or that perhaps are already providing, and the products. There are structures to aid in development that can — and the continuous improvement of a quality management system, they're really centered around that concept of you design it, you build it, you deploy it, then the control and then the continual improvement.

When is it the opportune time? Well, there are many changes that occur when regular laboratory operations that can impact quality. I think the key time is when you're standing up a new laboratory. Perhaps when you're expanding the disciplines or the specialties of your laboratory is testing for — expanding, otherwise expanding operations or then maybe onboarding or moving to a new facility or standing up a clinic. 

Bringing on new instruments or new methods, modalities, changes in kits, changes in existing testing processes. And so all opportunities to either re-evaluate your quality management system or if, it's the opportune time, then perhaps establish a quality management system. 

Now, laboratories do need to consider the policies that are going to be outlined in their systems. This includes the overall responsibility, the appropriate laboratory personnel and what those responsibilities are. Again, laboratory activities is, what's the testing going to be doing? What's the research? Are there considerations for, is it surveillance and outbreaks or is it emergency responses? What's the inventory?

This needs to — this needs to include technical and quality management requirements. What are the requirements for internal audits? What are the requirements for external audits? You know, certification and accreditation comes to mind. You want to ensure that this meets applicable regulatory local, federal, state, and otherwise requirements, and then again has this, this policy includes like the new improvement. 

Now a QMS policy should also provide flexibility for laboratory personnel to select a suitable structure for their intended use. And there was existing national or internationally recognized standards to build upon that we've mentioned — and that meets all standards — that meets the standard applicable regulatory and accreditation requirements. 

Laboratories can also customize again these recognized standards to align with their practices. Now, a customized QMS would need to meet, again, laboratory-specific regulatory and accreditation requirements towards that goal of that final system must have the flexibility to pass external audits.

Now, it should also include active participation on the part of laboratory's executive management and administrative director, medical director, managers, perhaps multiple specialties. And the supervisors of each laboratory discipline is vital to establishing and maintaining this quality culture and driving personal engagement. 

So this speaks to that expectation that quality is foundational. Part of that foundational aspect of quality is, does it meet with the ethical principles and practices of the laboratory operations and the facility that it's operating within? And those may vary between facilities. Again, this was spoken to earlier, but it's worth highlighting that it's all aspects of the laboratory personnel — senior leadership, managers, supervisors, testing personnel — really need to not only have the expectation that quality is foundational, but when we think about key steps for a culture of quality, it's buy-in, and what does that look like anywhere? 

Is it a posting of the quality policy? Is it a posting of the laboratory mission? Is it asking for feedback of those? Again, it's building a culture is perhaps more than just a printed document. Again, there might be areas that are exempt from aspects of the quality management system. Those should be discussed financial management, for example. And then we talked about active participation.

So this is — again, a laboratory's quality policy really is intended to define the culture of quality. The customers. Again remember those are that focused intent. What is the standard of service and the commitment to professional practice? Quality services and compliance need to be clearly stated within the quality management system and also the policy. And the commitment to compliance with applicable regulatory requirements.

But there absolutely has to be that buy-in and that support when it comes to audits. And incorporation into the laboratory's quality manual and other processes, it should be a well documentation of the scope, again, of what the laboratory will be providing, all the scope of services, and then how they're going to meet the expectation and needs of the customers.

Documentation, documentation, documentation. The quality management system should have the policies, processing procedures, and forms, all the physical aspects of it, as well, clearly defined roles and responsibilities. I mean that always towards that opportunity and provide ample opportunity during the reviewing of testing processes and the path of the workflow for improvement. 

So I won't go through this because of time constraints. But again, we do want to just provide some examples of there's multiple opportunities for not only the delegation but that buy-in. So some things can be delegated and, but I don't think buy-in can be. And so from the laboratory director, the supervisors it is not only the establishment of a culture of quality, but what are those practices are going to be done to go ahead and buy in? 

And so I think, and I do want to just end with, if there's any changes from that initial aspect of when we asked this poll the first time, are we all at C? Have some changed to As or Bs or perhaps down from there?

So I do want to thank everybody. And then we alluded to some, but just a selection of quality management standards and guidance when we spoke about CLSI. But there's also the ISO, the International Organization for Standardization. WHA — WHO, budding organizations like the CAP and I think and — CLIA. All right. I'll hand it over to Sabrina.

All right, perfect. Thank you, Diego. We just heard about the importance of evaluating the quality improvement plan in your laboratory. Now let's take a look at evaluating the risk management process. And I can also start my video. OK, there we go.

Now let's take a look at evaluating the risk management process. We know that both are equally important and that you should not have one without the other. The quality management process should be used to mitigate risk, and your risk management should be used to improve quality. There we go.

When evaluating your risk management process, we know that that is important. Risk management is the process of identifying and controlling risk in an organization. This involves managing policies, procedures, personnel, and resources needed to implement, monitor, and improve your organizational risk management. 

In your laboratory, your risk management strategies are used to prevent unexpected events that could harm employees, cause damage, or disrupt the operations. In order to create a safe environment, it is important to integrate risk management into daily laboratory operations. This includes regularly identifying hazards, prioritizing any risk, and establishing protocols that mitigate those risks.

Now, when you think about your risk management, it should be a collaborative process, meaning it should involve individuals with different skill sets within the organization. It should involve supervisors, investigators, scientists, technicians, as well as safety personnel.

The most important people in this process are those who work in a laboratory. Because of course, they know the hazards, they know the procedures that are involved, and they know the processes. And they can evaluate the effectiveness of the risk management strategy that you've developed. You want it to be dynamic, dynamic, meaning it should implement all operations, protocols, and activities. It should be flexible and able to, and be adaptable to any changes in the environment.

Continual: The risk assessment and risk management process should be conducted on a continuous basis, especially when there are unexpected changes in the workplace, environment, any policy changes, or there are procedure changes. Another important aspect is documented and communicated. That should be done in a standardized way so that everyone understands the objectives, any goals, any challenges, and the benefits of the risk management strategies.

Now, your risk management involves assessing, mitigating, and performance, which we may have seen this — also known as the AMP model, when you're assessing — your assessments. So let's consider this the first step where risks are identified and evaluated. That involves analyzing any potential hazards, understanding the likelihood and impact, and determining the level of risk. 

You'll also take a look at mitigation. Mitigation is, so once you've identified whatever that risk is, the next step is to develop strategies to reduce or eliminate them. Now, this may involve implementing safety measures, improving processes or procedures, or something like providing training to your staff.

And performance. So after implementation, your risk management — after implementing your risk management strategies, you should monitor and evaluate their effectiveness. Regular performance checks ensure that implement measures are working as you intended them to.

Now, let's take a look at something that's very common, such as the risk of slips and falls in your workplace. Here's an example of how the AMP model can be applied. You assess. So we walk through the workplace. We identify potential hazards that could lead to slips and falls, such as if there a wet floor, uneven surfaces, or if there's clutter that you've noticed. We evaluate the likelihood and the severity of those — any risk that could result of the things that we just identified. 

Then we take a look at mitigation. Based on our assessment, we implement measures to mitigate the risk. This may include installing nonslip mats, making sure there's proper lighting, or placing warning signs near the wet floor areas.

And performance. To ensure that there is effectiveness of the risk mitigation efforts, you need to regularly monitor and evaluate the performance. Now this involves conducting inspections to check for any new hazards or any maintenance issues, reviewing any incident reports. And you also want to seek feedback from the employees regarding any safety concerns that they may have noticed. 

Now, what we've seen is that, following the AMP approach in risk management for slips and falls, you can continuously assess the risks, implement measures to mitigate them, and regularly monitor the performance because you ultimately want to maintain a safe working environment. 

So when we take a look at risk assessments, we know that they are the foundation for safe laboratory operations, and that conducting a risk assessment should be viewed as a systematic process that's used to help you identify the hazardous characteristics of an infectious or potentially infectious agents, the likelihood that such exposure will cause laboratory-acquired infections, and the probable consequences of acquiring an infection. 

The information that you identified in the risk assessment that you've conducted, will provide a guide that is simply your guide to help you take the appropriate mitigation steps. Now, your risk assessments also evaluate what could go wrong in certain situations and consider what steps are required to reduce those risks to an acceptable level. 

And by assessing our risks, we make informed decisions and take appropriate actions to ensure the safety of individuals, protect our assets, and minimize any negative impacts. And we know risk assessment, like we said, builds the foundation for the overall risk management strategies.

Now, we know facilities should have a policy and process in place for conducting activity-specific risk assessments.

The risk assessment policy should outline the principles of your risk assessment, which includes identifying your hazards, analyzing your risk, and you want to also prioritize your risk. It also explains how the assessment will be documented and communicated to all staff members.

Once you establish that policy for your risk assessment, that describes — the policy describes how risk assessment influenced the implementation of control measures and performance management. So in other words, this is very important to remember, your risk assessment should be proactive rather than reactive. And the results of the risk assessment should be reported to senior management. 

So now that you've received all this information about risk assessments, I know you're asking yourself, when should I conduct a risk assessment? Well, here are some of the major points when you should conduct a risk assessment. Any time you're starting new work or making changes to the program of work, such as you're introducing new biological agents, that would be a time when you should conduct a risk assessment, if you have any modifications to laboratory equipment, any operations within a facility, or if you have new construction. And also when you have change in staff, that should be another opportunity for you to step back and take a look at your risk assessment to make sure all of your processes and procedures are working effectively.

Now, we will have a poll here, and it keeps jumping, but we do have a poll here just to do — this is a pulse check. So the poll question, risk assessments are conducted and reviewed, and you choose the answers that are correct. When there are significant alterations to the standard operating procedures, when unexpected events that may have relevance for the management of biorisk are observed, as part of our existing management system review process. For example, something that we do on an annual basis, or D, if you do it right the first time, then you should never, ever have to do it again. 

So we do have a couple of responses, and I'll give you all just another second or two. But like I said, I threw this in just as a pulse check and — spoiler alert here. The answers are A, B, and C. Of course, D — you know we want to drive home that of course you want to do your risk assessment right the first time, but it is one of those things that you should continuously do over and over. Thank you all for participating in the poll. We'll move on to the next slide. 

All right, so let's take a look at risk mitigation and it just keeps moving on its own. Well, let's take a look at risk mitigation. Risk mitigation is designed to eliminate or mitigate your risk to an acceptable level. Now, this is usually done through a formal or an informal process to ensure that, firs, procedures in place are significant to manage the risk associated with the safety and well-being of the laboratory workforce.

Leadership must acknowledge which risks are acceptable and what control measures are in place. And you know, we know that no two organizations are alike, and not every organization will make the same decision about which risks are acceptable. So this decision is based on the organization's tolerance of risk, and also the availability of resources to manage the risk at each facility. 

Now here are some examples of mitigating risk when you're evaluating your process and your facility. You want to ensure that equipment is regularly inspected, maintained, and calibrated, which — this can help to reduce the risk of accidents or errors caused by faulty equipment. You want to also take a look at staff competency levels. They should be documented and maintained to show that all personnel handling biological agents and toxins are competent in performing good microbiological techniques.

Let's say your facility conducted a risk assessment, and you determined that staff competency training could be improved. So we know that inadequate training of our staff that could lead to unsafe practices in the laboratory. So here are a few strategies that can be implemented to mitigate the issues of inadequate staff competency and enhance training effectiveness.

One, you can develop a comprehensive training program that encompasses both theoretical and practical aspects which — that should ensure that all necessary skills and knowledge are covered. You can offer ongoing professional development opportunities such as workshops, seminars, or online courses to keep staff updated on the latest techniques, technologies, and any safety protocols that have changed. 

You could implement mentoring-ship and shadowing programs to place less experienced staff with seasonal colleagues. Now this will provide hands-on learning opportunity, guidance, and it will also support in developing skills and additional competencies. And you can also ensure that the training program incorporates feedback mechanisms where you have written documentation of all training activities, and regular retraining or competency testing of the staff. And it's important to provide laboratory professionals with sufficient information resources, as well as time to develop good habits.

So here, we'll take a look at performance evaluation. Performance evaluations ensure mitigation strategies have reduced risks to an acceptable level. We want to be continuously evaluating performance, demonstrate the risk management systems success, and it helps identify where it needs to be improved. 

Some activities you can consider or — yeah, that you should consider and that are involved in the performance evaluation. If there's any findings during an inspection report or I mean, yeah, during an inspection that you act on those findings. You want to monitor controls as well as collect data from the controls you're monitoring. You want to report and evaluate results to leadership, as well as to personnel that are working in the facility. 

Now it's important that everyone is responsible for actively monitoring and evaluating the performance of the chosen controls. When monitoring the controls, you want to review mitigation strategies to identify what performance indicator should be monitored for each control measure. Now, here are some methods that could be used to collect data on performance. 

If you do audits within your laboratory, you want to constantly review the training records to ensure that they are adequate. You can take a look at incident and/or inspection reports. The results from the data monitoring should be used to evaluate the effectiveness of the implemented control measures. Your evaluation should be routine and continual. And it's also important, at this point, that you want to encourage open lines of communication so that from any of the findings, or if there's any, you know, information that you've noticed from the inspection report, that staff or everyone have an opportunity to feel comfortable reporting that information. 

All right, so this is our second pulse check for this section. Now, here, I want you to select the best answer: Which of the activities below are involved in performance evaluation? The options are A, acting on the findings; B, conducting the initial risk assessment; C, monitoring controls and collecting data; D, determining where the risks are acceptable or unacceptable; and E, reporting and evaluating results. So just a few seconds here. I see the results are coming in, and thank you all who are participating.

And the correct answer is winning by a lot. So I'll go ahead and let you all know, because I know you're just dying to hear the answer. So the answer is A, C, and E. And we had 45%. Thank you very much. And I will go to the next slide. 

All right, let's talk about communication. We know communication is an integral part of risk management. It plays a critical role in effectively identifying, assessing, and mitigating the risk in the laboratory. Risk communication serves to educate others about the risk and it can actually help change attitudes. Good risk communication helps to alleviate fears regarding risk or — and adversely, it can also help demonstrate that the risk is unacceptable. Risk communication should be part of a structured risk management process. 

So for this section, in summary or in conclusion, your risk management is essential for the success and sustainability of any organization. It involves identifying, assessing, and mitigating potential hazards and risks within a laboratory environment to ensure the safety of the personnel, the environment, and also ensure accurate testing outcomes. 

Evaluating your risk management process should be ongoing, and it should be adaptable. Embracing a proactive approach, when you're evaluating your risk management system, will ultimately lead to a more resilient and a safer future for the organization. So on this screen, here are some of the resources that have been developed and are available through the Division of Laboratory Systems to assist you in implementing and evaluating your risk management in your laboratory. 

I want to say thank you on behalf of Diego and myself. We appreciate you listening to our presentation. Thank you.

Thank you. We'll take a few minutes and answer as many questions as possible. Again, if we don't answer your question today and you have questions later after the sessions, please feel free to email the OneLab inbox at onelab@cdc.gov. Let's see what we have.

OK, we — right now, we just have one question. And this member wants to know. They want to thank you both as presenters and they would like to know, could you please share how your backgrounds, education, degrees, and passion led you to the field of quality and safety? I guess, Diego, you can go first. 

Well, I was just going to say, Sabrina, go ahead, because I think you're ready. Yes, I can go first. I'm sorry, Alicia, repeat that question. There were so many pieces to it. Yeah, they would like to know like for you to share how your background, education, your degrees, and your passion led you to the field of quality and safety. 

Background — I have a master's in forensic chemistry, forensic biology; a doctorate in health science. I came to CDC about 21 years ago, started as an inspector in a regulatory branch of CDC. And I've just been in this field for the last 20-21 years, and it's just evolved into staying connected with the laboratory community, as well as — now the branch that I'm in, we work with clinical and public health labs.

And over the last 20, is it 20 or 21 years? It's just my passion for working with the labs. It just keeps evolving, and I'm constantly learning from them, and they're learning from me. But it's just being in a field where you feel appreciated and valued, and it's constantly evolving. And I feel like everyone is learning at the same time. So yeah — that's my background. 

Diego, you're up.

Oh thanks, Sabrina. So I'm kind of a relatively late joiner to CDC. I did a lot of graduate work in biotechnology ... evolution of protein interacting domains and the way they evolve — protein engineering and then you know, back to current surface display. The point being is, I spent quite a bit of time in more like biotech, applied applications. And so I think it's seeing test development through test deployment and getting that actually approved and out the door into people's hands, I think is — was an interesting aspect. And I think I was lucky to see that from more of a developer side than then coming to public health and seeing that impact.

Then I did a stint in the inter-agency space, during COVID, always interesting times during COVID. I think the ability to then take what is being used to result a test and then how that is, impacts and informs policy decisions all the way up to the White House, kind of led me to this space of how to improve those aspects. 

And then as Alicia mentioned, I help with next-generation sequencing technologies, and then particularly with getting those method validations through and improved in both public health, clinical applications and we're kind of deep diving into that general mix. So a long way of saying is just that practical application of test development is fantastic, where getting it out the door and useful is, I think, really an interesting passion. 

All right, thank you. This question is for Sabrina. When you do a risk assessment, do you use one unified form or do you use forms specific for specific situations, such as a different form for changes to procedures, injury potential exposure, new equipment, etc.? 

All right. So — I will say there is no one unified form for risk assessments, what we've found, and this is the field that always says, it depends. So as far as the risk assessment, it depends on your institution. You can develop a risk assessment form, or if you're getting new equipment, there's so many different resources online. But I can say it will depend because there is not just a one specific risk assessment form. It does depend on the situation and the actual institution.

Thank you. Well, that seems like all the questions we have for this session. I'll give it a few minutes to see if one pops up. I don't see one. So I'll say thank you, Diego and Sabrina, for your commitment to safety and quality of clinical and public health laboratories.

Thank you for having us. 

You're welcome. We'll pause for a few minutes before the networking session that begins at 1:35 PM. Please use the link that's in the chat to join the session, where you can connect with your peers and exchange ideas. We'll see you over in the network section.