Biorisk Management Performance Evaluation

Transcript

Date of session: 11/19/2024

Facilitator:

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speaker:

Michael Pentella, PhD, D(ABMM)

State Hygienic Laboratory, University of Iowa

michael-pentella@uiowa.edu

Aufra Araujo: And good evening, everyone. My name is Aufra Araujo, and I want to extend a warm welcome from the Centers for Disease Control and Prevention in Atlanta, Georgia. I'm the CDC ECHO Biosafety Program Lead and the acting Safety Team Lead in CDC's Division of Laboratory Systems.

Thank you for joining our 10th Extension for Community Healthcare Outcomes, or ECHO, Biosafety session for 2024. The topic for this interactive discussion is Biorisk Management Performance Evaluation. Today's subject matter expert is Dr. Michael Pentella from the State Hygienic Laboratory at the University of Iowa. I'll stop sharing my slides just for a moment so I can see all of you. And let's see. I like to ask everyone a quick icebreaker question, which is already in the chat. And the question is, as we head into the holiday season, what's one food you look forward to each year? So if you can, enter your answers in the chat.

I see turkey. I will start by randomly calling on someone so we can get to know each other, and I will ask the person to unmute and respond and then they can ask. They can randomly choose somebody else in the audience this way we get the conversation going.

So randomly, let me look, find somebody. I'm going to go down the list. Gregory Powell, would you like to unmute and share with us?

Gregory Powell: Yes, good morning. So my favorite is, I'm here in Arizona, and we do more traditional southwestern style enchiladas for holiday foods. So that is what we will be doing.

Aufra Araujo: I love enchiladas.

Gregory Powell: As do I.

Aufra Araujo: So would you like to go ahead and call on somebody randomly from the audience?

Gregory Powell: Certainly. I will see who I can find here. Let us go with Jamie Bishop.

Aufra Araujo: Jamie, if you are talking, we cannot hear you. Maybe Jamie cannot talk. Do you want to call somebody else?

Gregory Powell: Sure, I'll give it another shot. How about Lisa Wallace?

Aufra Araujo: Maybe people cannot talk. Yes, but anyways, I'm glad you unmuted and showed your face. It's nice to see you virtually. And I see lots of options and food preferences here in the chat. Thanks, everybody, for participating. Yes, Jamie, you entered in the chat. You are called on to share about your food. If you are back, I'd love to hear your voice. And what you like for the holidays. What's your food preference? Got up for tea. Maybe she still drinking tea, no worries. Thanks, everyone, for entering your preference. I feel very hungry. I haven't had lunch yet, so this was good.

Let me share again the screen here and oops, center. Yes, you should be able to see the slides in presentation mode. Thumbs up if you can see. OK, perfect. Thank you. All right. So next, moving on.

Now, I'd like to provide a brief recap from our last session in October. It featured Dr. Christine Lawson, who presented on The Importance of Biosecurity in Biorisk Program Management. Christine defined biosecurity as ensuring the containment of necessary materials while restricting access to others, stressing the need for rigorous risk assessment and mitigation. Real-world cases highlighted the critical role of oversight, accountability, and suitability screening to prevent misuse of biological materials. The box on the screen. Sorry. The box on this slide shows a couple of participants' comments about maintaining a culture of security and safety that is supported at all leadership levels.

During that session, we had 139 participants attending and who were affiliated with 82 organizations. The state shaded in green on the map had participants from at least one organization. Also in attendance were participants from 13 national organizations. And at least one organization located in Belize, Canada, and Indonesia. We encourage you to share information about the ECHO Biosafety sessions with your colleagues and to connect with each other via chat if you'd like.

Before we continue, I'd like to address some technical aspects of our ECHO Biosafety session. Please use the video capabilities of your device for this session. Currently, all audience microphones are muted. When engaging in the discussion, please unmute yourself to speak. Closed captioning is provided through Zoom for this session. If you are experiencing technical difficulties during the session, please send a private chat message to George Xiang who is labeled as CDC ECHO Tech. George will do his best to respond to your issue.

If you are connecting to Zoom by phone only at the time of discussion, please introduce yourself by stating your name and institution before speaking. We encourage your active participation by sharing your knowledge and experience. Each laboratory is unique, and your skill sets are unique, so your contributions to the discussion are valuable. Next slide. Let's see.

So here is a brief description of today's session. I introduced our subject matter expert, Dr. Michael Pentella, who will provide a didactic presentation and a real case discussion. Then my colleague, Commander Folasade Kembi, will summarize today's discussion. Closing comments and reminders will follow, and we will adjourn this session.

Today's session is being recorded. If you prefer not to be recorded, please disconnect now. The transcript, audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website a few weeks after today's session.

I'd like to remind everyone that these slides contain presentation material from speakers who are not affiliated with CDC. Presentation content from external speakers may not necessarily reflect CDC's official position.

Now, it is my pleasure to introduce today's presenter. Dr. Pentella is the Director of the Iowa State Hygienic Laboratory. He has a Bachelor of Science degree from Ohio State University in microbiology, a Master of Science degree from Thomas Jefferson University in clinical microbiology, and a Doctor of Philosophy degree from the University of South Florida in infectious disease. Dr. Pentella has over 40 years of experience in the clinical microbiology laboratory and over 20 years of experience in hospital infection control and epidemiology.

He is certified as an American Board of Medical Microbiology Diplomat. He is a member of several national committees and past chair of the APHL Biosafety and Biosecurity Committee. It's particularly fitting that just one week before Thanksgiving we have the privilege of hosting Dr. Pentella at today's session. Dr. Pentella, we are grateful to have you with us to lead this ECHO Biosafety session. The floor is yours.

Michael Pentella: Thank you, Aufra. Thank you very much for that kind introduction. And I'm going to share my screen. And are you seeing the presentation slides?

Aufra Araujo: Yes.

Michael Pentella: Very good. Well, thank you, everyone, for joining us today. This is a different presentation than what you're used to. Actually, I'm airing dirty laundry because we went through a biorisk management performance evaluation here at the State Hygienic Laboratory. The State Hygienic Laboratory is Iowa's public health laboratory. And I'll tell you more about it in a few minutes. But this is a good chance for us to share this information, and it was a good experience for us. We learned a lot.

So our objectives today are to review the pilot program that we participated in, understanding the planning and audit process and consider the value of performing an audit of your biosafety program, something that you may not get an opportunity to do. And we took this opportunity because we wanted to participate, to get to know from an outsider's perspective, what our biosafety program was like. Is it meeting all of our goals and objectives?

You're real close to your programs and it is wonderful to have another set of eyes from the outside, come and look over your program and give you feedback. And having the ISO 35001 standards to utilize was really a great opportunity for us. So I'm going to supply you first with some background information.

For those of you who are not familiar with ISO 35001, this is biorisk management for laboratories and other related organizations. It was first published in November 2019 by the International Organization for Standardization, ISO, and it outlines a process to identify, assess, control, and monitor the risk associated with hazardous biological materials in a laboratory setting. It is for any institution, not just clinical and public health labs, but any institution that works with or stores, transports, and disposes of hazardous biological materials. And it's intended to complement your existing standards or other guidelines for the laboratory.

So that's the purpose of it. And it's developed into seven different principles, which I'll share with you on this slide. So the principles are the context of the organization - so as a public health laboratory, providing testing services throughout the state - and looks at your leadership and planning and support for operations, my performance evaluations, and improvement. It really looks at biosafety as a continuous quality improvement activity, which is a really excellent way of looking at your program.

So we had this opportunity through collaboration with CDC and APHL, and they have an implementation project and we were one of the pilot sites. And this allowed us then to work with outside auditors. And our goal was to improve our internal processes, to reduce incidents, accidents, infections and illnesses that may result from laboratory operations.

And it came at a very opportune time, because in the prior several months before this opportunity arose, I had seen two instances of exposures in our facilities. Fortunately, neither resulted in laboratory-acquired infections. But two incidences of exposure that made me question how good our program really was.

And to give you some more background, we had lost our biosafety officer and then our new biosafety officer joined us. And so we were looking at it from a different perspective. But as you'll see during this period of getting ready for this audit, the second biosafety officer was offered a better position within the university and elected to take that position, and we wished her well. And so with that, put a little ratchet into this preparation process.

So you get these gap analysis checklists and it's very helpful. It's intended for any laboratory interested in implementation or accreditation towards ISO 35001. And the checklist is for the laboratories internal use only. The purpose of this tool was then to guide us for that on-site consultation of select laboratories that are seeking ISO implementation.

It was really interesting going through this. Originally there were four of us, but after Norma left for the other position, there were three of us who went through this gap analysis checklist, and myself, Eileen Moran, who was a Laboratory Leadership Fellow with us from the CDC, and she has since left us for another position. And also, my administrative assistant helped us because it took a lot of organization and putting everything together for the checklist. So we had four of us who started on this, and we really made really good progress. And we started on it in September of 2023.

So going into the next slide, I'm going to give you a knowledge check here. So I want to check your knowledge on this question. What other ISO accreditation do clinical and public health laboratories typically aspire to? Please answer the poll and let me know how familiar you are with ISO 17025 and 15189. So George, will you let me know when participants are completed with the poll? We have the poll. And I believe everyone is seeing this. It's poll number one. And the correct answer is both, 17025 and 15189. And 57% of you knew that information. So that's terrific. So your knowledge of ISO is very good. Let's go on to the next slide.

Just some facts about the State Hygienic Laboratory. We're located in three locations in Iowa. First off, there's Coralville, which is the largest of the three laboratories. And then a facility near Des Moines in Ankeny, Iowa, that does newborn screening and environmental testing, particularly metals. And the Milford, Iowa location, which is in Northwestern Iowa. It does mostly water testing and services around that area of the state since it's so far distance-wise from the other laboratories.

So we have over 110 clinical and environmental sciences. We have over 200 employees total. There are 15 fellows and interns. We get not only the CDC fellows - Jessica Wickline is currently with us - but we also have fellows from APHL. We have three fellows at this time. And we get interns from the University of Iowa and students from the College of Public Health who are doing practicum projects. We have over 170 very specialized instruments and methods. And we do get audited for ISO 17025.

So we have two divisions in our laboratory. An environmental health division and a diagnostic clinical division. We're part of the University of Iowa. We're one of only two across the nation are actually under the direct supervision of the university. So in my role as director, I don't report to the health department or in state government. I report to the vice president of research, who reports to the president of the university, who reports to the Board of Regents, who are appointed by the governor of the state. So it's a little different structure.

During COVID, it was really beneficial to us because it really gave us a lot of resources to call upon. And a lot of people from the University came into our laboratory to perform testing, particularly at the beginning when research was shut down at the medical school campus and throughout the University. So it's a real pleasure to be here at the University of Iowa.

So let's go into the evaluation and planning process. And this is just a picture of our lobby when you walk into our laboratory. So we started talking about this in July 2023 when we had discussions with CDC, APHL, and Dr. Julianne Barron, who was a consultant in this project. So we talked about it internally during the month of August and had a kickoff call in September. And we really got started on how we would organize ourselves to look at this gap checklist and how we would communicate. We set up a SharePoint site on how we would work together. We divided up the checklists so none of us would be overly burdened.

Then we went into some planning. Putting together our work plan on how to finish this. And we really made a lot of progress in September. Our biosafety officer left us in October. And to be frank with you, I was really tempted to cancel on this project at that point because I didn't feel like we could. But I got together with Lauren and Eileen, and they encouraged me to move forward and that we could get this done with the three of us. And that was the correct decision. So we continued on. We did ask for a little bit more time because they were originally scheduled to join us for the on-site in November, but we decided that we needed more time to go through everything.

And they came in January. They had the exact visit in January of 2024. Then in February, we got the findings. February and March, they gave us the findings. And I shared that widely throughout the laboratory. And then we have participated in joint calls with other pilot sites since then. And we're going to participate in an on-site visit to the Florida laboratory in Tampa with other pilot types. New Hampshire will be there as well, and that will be in December of this year.

So this is our timeline, our work plan. But the real key is answering the questions. We started foundationally by creating that SharePoint site so we would have a site to place all the evaluation materials. Everything that would show our ability to comply with the item in the checklist. So we compiled a lot of resources. And we were chosen to be organized by the seven different principals. So we elected to take the seven different principles and align our guidance documents with those seven different principles. And this was a way for us to organize these materials and to make sense of what we were doing and see how things were connected.

So that worked out well for us. And this picture on the right is just our gap analysis from SharePoint. Then, we got our assessment report back to us before we actually had an on-site visit. We recognized something really serious, and that was that we really didn't have a biosafety and biosecurity policy that included everything. There were was one for the VSAP program, but there wasn't an overarching policy and it was parts of other procedures. It was there, but it needed to be compiled. So that was a big effort to get that accomplished. And now we have it.

This is a picture from our document system called iPassport. And we have the document in place now. So that took some time to get that through a draft phase going through our various committees, our quality management team. So the in-person evaluation came in. This picture of the laboratory with the snow covering our front was very deliberate because it happened to snow during our inspection. And that created some additional challenges for us which is very unusual. But the university closed because the snowstorm was so serious. There was about 15 inches of snow that landed. And that was another snag or snafu in the process. But looking back on it, it all went well. We had Zoom capability. And we moved to the Zoom format and everybody continued to participate.

So here's my first discussion insert for us. What do you see as the positives and negatives of participating in this evaluation? Some of you may be thinking, why would anyone volunteer to do another audit? We have so many auditors coming to our laboratory. And I think that's a very good question, but what do you guys see about the positives and negatives about participating in this type of audit? So please take yourself off mute and contribute to the conversation or add something to the chat. But I really would like you to come off mute and share your thoughts on doing this. So I'll watch the chat here.

Randy Albrecht: Hi Michael, this is Randy from Icahn School of Medicine at Mount Sinai. I like these endeavors because it does give the institution a chance to take a leadership role in implementing these processes and helping identify any bugs or gaps in the system.

Michael Pentella: So you see the value of the outside eyes as well?

Randy Albrecht: Yes. And especially if it's in a pilot stage to really help shape what will be implemented to a broader community, assuming that leadership role is attractive.

Michael Pentella: Yes. So many people have said to me it's difficult to get leadership engaged in biosafety activities. And I think going through this type of checklist is one tool that you can use to get leadership engaged. Thanks, Randy. We have a couple of comments in the chat. Aaron adds positives. You don't know where your limitations and problems are until you look for them. I absolutely agree with you. And Tyler adds one helps one get material together and evaluate where they are prepared. And that's exactly true. I would have never recognized the gap of not having an overall policy unless I had done this. And it helps the institution to overcome their own biases. Absolutely true.

We want to think that we're the best ever at something. And you may point to several factors to substantiate that. But the truth is, an outside set of eyes that is looking at actual standards really helps that. And Stacy adds, "See BS&S from another perspective from the agency being audited." Yes. And negatives being additional time commitment and redundancy. And that certainly was a concern of mine because I know that no organization really has much free time. And you lose people, as we have, throughout an organization. And after the pandemic, I think from our perspective, in 2023, after the pandemic, we were still pretty tired from having gone through that.

We performed around 2 million tests for SARS-COV-2 because we were doing the Test Iowa program. And that really, literally, burned us out somewhat. But we got our energy back. And, Russell adds, focusing more on safety and risk assessments is a plus. Yes, because when you go through other audits and things, it doesn't have just the biosafety focus. And it's a must in the laboratory, I agree.

And Jonathan adds, my institution has done similar audits in preparation for subsequent audits by accreditation agencies. Yes, that makes a lot of sense, Jonathan. To have an audit before you're inspecting auditors, to find those last few things that you can clear up before the auditors come, I think that's always a really good idea. And I've practiced that when I was in the hospital environment under the CAP accreditation standards. I would do it on a monthly basis. I did that for a couple of years before they came again to get us up to par because I thought we need to be thinking of this more routinely. And I think it's very helpful to do it before the auditors come.

Always useful to have an additional set of eyes per Joseph. And looking over the program, that allows for more familiarization with ISO 35001. Yes, and enhances top management's perspective. So lots of positives here and builds that commitment from top management. Helps to identify blind spots that the organization may not be aware of. Absolutely. And Rebecca, outside eyes see things and say things differently, which can help direct resources and administrative support, which are often limited for biosafety and biosecurity.

So, Joseph adds, it's a responsibility of the organization's leadership to be audit-ready. Yes, we like to think that we're ready for an audit at all times. And we hope we are. But we know, especially in a large organization like mine, leadership can't know everything. And this helps us know more about ourselves. So it's a real positive from a leadership perspective.

Well, I can see from your comments that you're on board with me in doing this. And I really do feel like it was the best thing to do and for our program. And I will go into a little bit more about this now. I wanted you to see how many people participated because this is one of the real pluses to me. We're really focused on reviewing documents and things. But the auditors met with so many different groups.

Haley Sinn and Nyree Mortensen are from the university, and they're from environmental health and safety. Haley is the director and Nyree is the responsible official. So having them meet and talk to the auditors was a real plus. Then our safety committee, we have a safety committee that meets monthly, and they arrange to have their meeting at the time when the auditors were there. And it was chaired at that time by Angela Goetzinger. And other participants from our Ankeny facility and our Coralville facility are all listed here.

I did not attend the meeting because I wanted people to speak freely about our biosafety program. And I was thinking that having the director present may lead to people not feeling comfortable sharing all their thoughts. So I opted not to participate in any discussions. Of course, they met one-on-one with our biosecurity officer, David, and our associate director, Cynthia Cass. So those were good. And that continued into the next day as well.

Just to list some of the different areas. These folks are from accessioning, and other areas throughout the laboratory, and microbiology section. Then the environmental supervisors. Dennis is from the lab in Milford, Iowa. He met by Zoom. And Terry Cain from Coralville. And Jessica from Ankeny. So a large list of individuals who met with these folks, with the auditors. In the clinical supervisor discussions, also a large list of individuals. They met with our quality team and our training coordinator, and then they met with me.

So it was really a lot of people. We got a lot of feedback. And the feedback I got from people who met with the auditors was they had a positive experience. They really felt good about what they were able to share with the auditors. And they felt good about looking at the biosafety program and sharing their concerns with the auditors. So this was really very helpful and was a success. So they had a total of 10 discussions. So 25 staff were in person, others were by Zoom, and they met with all the biosafety committee members.

I think I was wise not to be a part of it, because I do know that, even though I hold listening sessions with our staff, that sometimes people are not comfortable sharing everything that's on their minds. I think people are much more comfortable sharing with people that they're not familiar with than with leadership itself. So this was good. So our challenges, I've mentioned the BT coordinator's departure. Our everyday challenges of events like inclement weather. And it takes a lot of time to think about where these documents are that are substantiating our compliance with the standards.

So I found that it was best for me to do it on a Saturday or Sunday so I could dig through and see what did we have, what was the documentation that we needed without interruption. So that worked well. Having a timeline really helped us, and we persevered despite the weather challenges. We had a closing session, and everything went well.

And then we got our report. And that's the important part of this presentation. And this is where you're going to see the dirty laundry. So this was separated to the gap analysis into four evaluation options. Yes. Yes with suggestions. No, we did not meet that standard. And the fourth option was not applicable to the laboratory. We had 20 conformances with suggestions and nine non-conformances.

So I'm not going to review with you the conformances. There were many, which is real good. But there were also these 29 either conformances with suggestions or non-conformances. So it's really important that this is broken out in this way because it really helps us to evaluate what we need to do next. Of course, you would think the nine non-conformances were the top priority for us to follow up on, and that is what we tried to do. But I'll try to clarify what we have done next throughout talking about these.

But first I want to go into the conformances with suggestions. So under 5.1, these are the conformances with suggestions. And it's really important to look at the comments that they gave us. Because they looked at our existing committees that we have, with the safety committee and the quality committee, and they felt that was good. But our specific problem was that we didn't have biorisk management objectives written. They were hinted at, but we didn't write them. And our objectives needed to be written in the SMART format. So we had to include this in our metrics so that it could be tracked. And so this was very helpful to us to have these comments to us.

And if you go on to some more conformances with suggestions. These were very. Helpful because it identified that the current process for worker health and vaccination relied on the supervisors in conveying information to human resources and occupational health. And that was very varied by supervisor. There wasn't a standard way to do that. So one of our follow ups right away was to develop a standard tool that the supervisors now use to communicate with HR and with our occupational health program. And following up with occupational health, I learned that other areas of the university had a standard tool already. So they shared it with us and we just modified it and use it.

And we also wanted to standardize our onboarding process. And it was recognized that our onboarding for biosafety was not standardized sufficiently. So now we have the biosafety officer, Andrea, meet with all new employees. And that sets the tone from the beginning. And helps our biosafety culture because they're meeting with the biosafety officer and learning about their expectations of their work at SHL. And that really helps us a lot, and we decided that we would also have new employees meet with our quality manager as well so that they're spending time learning about quality, and at a separate time learning about biosafety at SHL.

And this is, from my perspective so far, has really helped changing our culture at the laboratory. We're going to be doing a survey of that in the coming year to make sure that it's reaching the goals that we intend for this. We also looked at competency and training. And it can vary by department and supervisor, so we're looking to standardize that in this coming year as well.

Unfortunately, everything you have can't be accomplished in a short time period with all this happening in a busy laboratory. So we have things spanning the next two to three years. More conformance with suggestions. That was brought up about general training provided by UI, but internal SHL supervisors provide their own training. And that can be more reactive and just in time. So we want it to be more proactive in the future, so that's being considered from that comment.

And we also looked at our safety messages and how we communicate. And they suggested better communication. We communicate via email, but that can be missed by some staff. We also, and I'll bring this up, have other means of communication. But we have to look at that very closely and we're doing some things to improve our communications.

And then under 8.92, during that relative workers are trained, it was noted that staff could use more training. And providing additional training and exercises on emergency response plans is needed and we have plans for doing that. We've already started this year and we're planning to continue into the next year and make it on a regular cadence for us so that we're able to do more of this under 8.94. We had our continuity of opportunity of operations plan in existence, but it needs review, updating approval, et cetera. And the suggestion was provide additional training on COOP. And that's something that we've been working towards in getting more people knowledgeable about COOP.

More conformances was suggestions in this area of 9.21. Our audit policies and procedures mostly covered quality management, didn't cover biosafety. So we are adding our biosafety risk management and safety component to our audit policies and procedures. And we're going to engage more individuals in the self audits. We are putting some incentives in place to encourage people to do that. We hope to have that in place this coming year. And so we want to have a real thorough audit process. And this audit that we have for ISO 35001 identified that our process was weak. And also management review process exists. We go through that every year, but it wasn't specific enough for safety topics or biorisk management objectives.

So more conformance with suggestions here. A review exists of our risk management program, but it really wasn't sufficient enough. So this is an area for improvement. And we want to better link this to our continual improvement process. So that's been identified through these guidance documents. And we'll share with you some more of this. But here are some more of our improvements, conformance with suggestions for improvement. Promote the participation of workers in implementing actions for continual improvement. So we needed more communication in this area and sharing relevant results in getting more buy in from staff with this process. And we've done some of this, but this is not an issue you solve overnight. So this is something we continue to work on.

And then are non-conformances. So the meat of where we need to go here. On the next slide, the first one being planning. We need to have a biorisk management objectives in place that are written as SMART objectives and that did not exist. But does now, and I'll share those with you in a minute. And shall retain and document information on our objectives. So having these SMART objectives allows us to do that and can be tracked for our biorisk management program. And that can help guide our continuous quality improvement activities.

Now, here's a SMART knowledge check for you on SMART objectives. So I've given you three choices here, A, B, and C. Would you define SMART objectives as A, sensitive, mastered, accountable, rational and tenured? Or B, specific, measurable, achievable, relevant and time bound? Or C, short, mindful, accelerated, relatable techniques? So please select A, B or C for this knowledge check. OK, let's see what you've answered. OK all but one of you got this absolutely correct, and maybe the one person was probably kidding. So great you guys are very knowledgeable about SMART objectives. I'll go on to the next slide.

Does your lab currently use SMART objectives? This is another polling question for yes or no. Do you currently write SMART objectives? So I've admitted that we were not doing so. Feel free, this is completely anonymous, so you can tell us whether you're using SMART objectives or not. Let's see. Well, 55% of you are not yet using SMART objectives, but 45% are, which is very good. And I think that I can understand why that is because we were not knowledgeable enough to do it. We didn't have the skill.

So my insert here for our discussion is what do you see as your barriers to using the SMART goal model in your laboratory? Our barrier was mostly we weren't knowledgeable about how to write them. So I'm looking at the chat, and anyone can take themselves off mute. So I see some people are creating something similar.

Did you include, or were, sentinel outreach coordinators involved with sharing this information with facilities throughout the state? We have not gone beyond the lab with this information so far, but that's a really good question. We do send biosafety messages throughout the state, but I haven't talked to them about ISO 35001. I'm thinking we need to do a statewide webinar on biosafety and biosafety plan. And that was my goal, maybe, for the first of the year.

Someone here is curious about our thoughts on the personnel reliability issue. Concerns ever since ISO 35001 was released on what this should might include. That's a really good point, and I'll address it a little bit at the end of going through some more non-conformances. Great. Let's see. Hard to write. Yeah they take a skill to write them. There should be a practice session that you can do on writing it. I think that we can learn a lot from it.

So I think this is very helpful. You can read these chat comments. I'm going to go on to the next insert and that's on operations. We had some problems with-- we were doing fire drills and BTCT drills were performed for the folks that participated in the BTCT programs. But we didn't do spills, exposures, threats as a routine drill. And we have been since then. We've written up a couple of drills and we plan on continuing to do that.

The next slide looks at more non-conformances. Looking at our continuous quality improvement activities. And we have non-conforming events in compliances and training is tracked, but we need to do more internal audits. And writing this as a SMART goal is one of our objectives. And the more non-conformances on performance evaluation, there's not really an organizational risk management objective. As I mentioned before, we have to get those in place and we have to write them as SMART goals. And that's what we've been working on. And I'll show you in a few minutes what we've written so far.

And so it's basically going through our performance evaluation was lacking. And we need to create these SMART objectives and build this into our continuous quality improvement program. And just to summarize all this, in the interest of time, you see we had really strong conformance with the deep blue bars through the context of the public health lab. The leadership is strong. The planning is good. Good support. Operations good. Our performance is lacking and our continuous quality improvement is lacking. So overall, we scored an 83% through all of this, which I would say for our first go at this in recognizing our problems, I'm very pleased that we have so much conformance. And that made me feel good about the program.

But we've been working to improve it. And I'm going to ask you, how is relevant information on biosafety communicated with your staff? Because I think our communications is at the root of our problems and would like to ask you, what are you using to communicate biosafety information? So anybody wants to get off mute and share that would be great. Not seeing any typing in the chat either so maybe this question hasn't generated a lot of interest.

But there are several communication routes that you can use. And people are now typing. Email blasts, broadcasts, weekly meeting about bringing up biosafety topics at weekly meetings. Having people review policies and having your biosafety as part of your SOPs during the inspections. This is great. This is great. So I will share with you guys what we are doing.

We have all staff meetings and we make a point at the all staff meetings to always have a biosafety item for people to hear about, ask questions about. We do this message of the week. I always write a piece for the message of the week, and we send out in the message of the week biosafety topics as appropriate when appropriate. We have bulletin boards dedicated to biosafety. We have our safety committee and our emergency preparedness committee.

Emergency preparedness is mostly dealing, of course, with emergency response. But these two committees are permanent committees that people rotate after three year terms on and off the committees so we always have new insight from new individuals on these committees. And each year the committee reviews its mission and they set up their goals each year. So I'm going to show you the safety committee's goals so that you can see that we are now writing them in the SMART goal format.

But first some of our other solutions was this medical examination form that we put in our iPassport system. So each supervisor can check off what the vaccine needs of the individual is. So if somebody transfers in from one department to another, which happens sometimes, they need to relook at these vaccine needs. And of course, each new hire has the same form to fill out to go to occupational health and take it with them so they're aware of what the person needs to get. We have in-person fire drills. And we're doing spill drills and trainings and the safety committee goals, which is on this slide here.

For lab week, the safety committee put together this crossword puzzle. But I wanted to share with you the goals that they've written in the SMART format. So they always review injury reports and safety assessments and offer recommendations and corrective actions. Of course, those are de-identified. They don't know who the individuals involved were. But they do know that the event occurred and offer us insight. And I often attend the safety committee when my schedule permits so I can hear directly from them. And it's really good to get their insight.

They have, as a goal, discuss safety-related concerns brought to the committee by the committee membership. And then just let's see this one. By December 31, 2024, perform one biological and one chemical spill drill with each SHL department. So, by department, they mean the environmental health and the diagnostic clinical division. So they have these SMART goals in place now. And they serve as a good group of experts to advise us on writing these goals.

So discussion insert number four. Do you use an electronic quality management system, such as iPassport? This is the system where we keep all of our documents. We have all of our procedures that go through the authorization process, all of our validations, all of our non-conforming events that we've investigated and performed the root cause analysis. We even insert into iPassport our PTs, our proficiency tests. So that's where I go to review the results of PTs.

So do you guys use something like this? So Carol shared that they use Media Lab and Compass. Some of you use iPassport. This is great. MediaLab. So iPassport in Orange County. So this is really great. I'm glad to see that many labs are using this and encourage others to think about it, because it makes review of and other documentation stories so simple for us. So it's well worth the effort. OK, so we're going to do a demo of iPassport when we're at this meeting in Tampa with other labs. And we're hoping to see other laboratories pick up systems. I'm not a proponent of only iPassport. I think other systems are just as good.

So one of the things that we learned through this, too, that I wanted to share with you is we had not done a validation of our autoclaves. This is a picture of our new autoclave in our BSL-3 lab. And I had never been through a validation procedure for an autoclave before. So this is something that came out of discussions with the New Hampshire Public Health Laboratory. And we, of course, always run biological indicators. But where to put them in the bags and where to evaluate the autoclave performance was not part of our protocol.

Now, when we got this new autoclave, we did this validation and it failed. And we brought the manufacturer back in and now it's working satisfactorily. But found we probably would not have caught it without having gone through the validation procedure. So really grateful for that. And I'm sure that New Hampshire and Florida and Iowa will share that validation method with you in the future.

So another discussion insert. If you had those stands available to you, would you use them to do an audit of your biosafety program? Now they're not currently available, but just wondering if people are interested in that. I'm getting a lot of yeses for this, so that's great. OK, so-- wow. OK, very good. And then I'm going to go on to our last discussion question.

Have you heard any ideas during the session that you intend to use in your laboratory, and can you share them? I really like hearing from all of you. I've showed you our challenges, our areas that we need to address. And I'd like to hear have you heard things in here that you'd like to address at your facility as well? OK. Gap analysis worksheet, that would be good. SMART objectives, learning more about writing those and implementing more SMART objectives. Yes. This provides you today with some ideas that you can use in your own biosafety program. Yeah, it does start with the awareness. And doing that gap analysis is very helpful. OK, standard and using it to compare current processes - yes.

Well, I think that we have shared a lot of our experience with you today. And I really must tell you, I am a real proponent of going through this process, auditing your processes, and linking your continuous quality improvement program to your biosafety program. And it really will help identify gaps. It helped us a great deal. And I really feel good about it because I get the sense now we've had, since this experience, it's now going on a year, when things have occurred in the area as a potential exposure and things have happened, as in any laboratory, they will happen, I get the impression from the staff that our culture of biosafety has greatly improved through this process. And that they are really willing to identify potential risks and point them out to us far more readily than I think happened in the past. So I really do feel good about what we went through. And I'm really glad we did this. And very grateful to CDC and APHL for making this opportunity available and appreciate all that I've learned through it.

So anything else anybody would like to add? I think I'm right on time, Aufra.

Aufra Araujo: You're right on time, Dr. Pentella. Please join me in thanking Dr. Pentella for an excellent presentation. This was just really great information. You can see based on the comments, and several folks saying they are creating their own gap analysis and they just started developing their own biorisk management objectives. I'm thrilled about that. So thank you so much, Dr. Pentella. And I'd like to invite Commander Folasade Kembi to provide a summary of the discussion today. Today, you have five minutes. Go for it.

Folasade Kembi: OK. Thank you so much, Aufra. Thank you also, Dr. Pentella, for the presentation. So the summary of the discussion is as follows. It started with a question about whether the checklist is going to be shared. I think Aufra already responded to that well; they were not able to share the checklist at this time just because of the copyright implications of the ISO 35001. Then Dr. Pentella asked about the positives and negatives of participating in ISO 35001 audit. There were a lot of positives and just one negative.

And the positives include it helps facilities to get materials together and evaluate themselves, even as they prepare for the audit. It also helps the institution to overcome its own biases. Some said it doesn't. You don't know your limitations or problems until you look at them. Some believe being audited helps you to look at your program from another person's perspective. It helps to focus more on safety and risk assessment, and it's a plus. It's a must in the lab. It helps them to prepare for subsequent audits or similar audits by accreditation agencies. It also helps to familiarize themselves with ISO 35001. It enhances top management commitment. So there were so many positives about that.

But the only negative is that for participating in an ISO 35001 audit, it says you need additional time, commitment, and redundancy. So that was the only documented negative. Then the discussion continues about what organization performed the audit. CDC and APHL are responsible for the audit. Then there was also a question. Did you include or were sentiment outreach coordinators involved with sharing this information with facilities throughout the state? And Dr. Pentella responded that they have not gone beyond their lab, but they do send biosafety messages throughout the states, but may do a webinar at the beginning of the year next year.

Then there was also a short discussion on writing SMART objectives. A lot of participants agreed that it's very hard to write if they are not used to writing it. And some said sometimes it is hard to identify goals and some metrics are not easy to measure. Another point of discussion is how you communicate your biosafety information. A lot of people use email blasts. Some do weekly meetings to discuss biosafety issues. Some, safety meetings. Some, the IPC. Some, policy management software, LMS, education, training, monthly biosafety teleconferences and webinars. And some during inspections. During their lab audit, they do protocol review. They talk about results. And some also do biweekly lab reports.

There was another question that for quality management system, what do you use? Some laboratories use iPassport, and others use MediaLab and Compass. Then I think the last discussion was, have you had any ideas that you can use in your biosafety program during this presentation? Some said gap analysis worksheet. Some are going to go with the SMART objectives. Somebody said already have the standard and they are using it to compare their current process and what information can be borrowed. And somebody said, starting with awareness of ISO 35001. So those are the discussions.

And that was a point, I don't know if Dr. Pentella can respond to that, there was a question about somebody getting curious about personnel reliability issues. The person had concerns and he doesn't know how people will take it because of the invasiveness. Let me just read it. "I'm curious to get your thoughts on the personnel reliability issue. I have had concerns ever since 35001 was released on what this should or might include, knowing how invasive some people may think this component may be." I don't know if you just want to respond to that. But if not, then maybe the person can contact you.

Michael Pentella: I am happy to respond to it. and our experience here in Iowa is they do on hire a background check. And of course, the Select Agent Program does a much more in-depth background check. But they validate the individual's credentials and things like that. It's not as deep, I don't think. I'm sure it's not as deep as the Select Agent Program, because we have people who go through the Select Agent Program as a separate issue as well. And of course, they contact references.

They don't hire an outside agency to do an in-depth analysis, though, as some professionals do. I know I went for a job. I was in Massachusetts for a while. And before I took that job, They did a complete in-depth search of my profile. And they came back with, I had not paid the full amount of a property tax and still owed $0.45. I misread the bill and short-changed the Johnson County property tax assessor by $0.45. And said in order to get the job, I had to pay Johnson County $0.45, which I did. But I assumed from that, boy, they did an in-depth look. And I know we don't do that kind of in-depth look here in Iowa. But that does-- I think we get a lot about reliability from following up on people's references.

Folasade Kembi: Thank you. Dr. Pentella. Over to you, Aufra. Thanks.

Aufra Araujo: Thank you so much for your terrific presentation, Dr. Pentella, and for the summary study. Also, a big thank you to all members of this biosafety community of practice for participating in the discussion today. I have a few announcements that I'd like to share with you all before we conclude today's session. First, I'd like to discuss the post-session survey. The QR code on the slide and the link in the chat will take you to the Qualtrics survey.

This survey should take no more than two minutes to complete, so please, please, please do complete the survey. No unique identifying information will be sought or kept and the feedback we receive will be summarized in aggregate only. So it's completely anonymous. Your participation is voluntary, but we strongly encourage it so we can continue improving the ECHO Biosafety Program and achieve better outcomes with this community of practice. We appreciate your time in completing the survey.

If you have any questions about the survey, the ECHO Biosafety sessions, or if you have a laboratory biosafety challenge you'd like to present during the ECHO Biosafety session, please reach out to us at dlsbiosafety@cdc.gov. And this is fitting, again, because Dr. Pentella mentioned the standard, and here I have instructions. We are offering the license for the standard. So you see information here in this slide as part of the DLS Laboratory Systems' commitment to biosafety and biosecurity, we are offering free access to the ISO 35001 standard. And you see instructions on how to contact us to gain access to the standard.

Let's see. And here is the information. You can send us an email with the information listed here, and then we will respond with instructions on how you can obtain the standard free of charge.

For the next session in December, we are excited to have our next presenter. The topic of discussion will be Biorisk Management Improvement presented by Patricia Olinger, who is the Chief Relationship Officer at Y2X Life Sciences and President and CEO of Beams, LLC.

As a reminder, the transcripts, audio recordings, and presentation slides from previous ECHO Biosafety sessions are available on the DLS ECHO Biosafety website, which George will put in the chat. And with that, we will adjourn. Thank you for attending today's session. Happy Thanksgiving, everyone. And I hope you are intentional about having a safe and fantastic day. And we look forward to seeing you again in December 19. Sorry, December, 17 at noon Eastern time. Bye.

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