Planning: Developing and Achieving Biorisk Management Objectives

Transcript

Date of session: 04/30/2024

Facilitator

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speaker

Michael Stevenson, PhD

Deputy Lab Director

New Hampshire Public Health Laboratories

Michael.J.Stevenson@dhhs.nh.gov

Aufra Araujo: Good morning, good afternoon, and good evening, everyone. My name is Aufra, and I want to extend a warm welcome from the Centers for Disease Control and Prevention in Atlanta, Georgia. I am the CDC ECHO Biosafety Program Lead and the Acting Safety Team Lead in CDC's Division of Laboratory Systems. Thank you for joining our fourth Extension for Community Health Outcomes, or ECHO, Biosafety session for 2024.

The topic for this interactive discussion is Planning: Developing and Achieving Biorisk Management Objectives. Today's subject matter expert is Dr. Michael Stevenson from New Hampshire Public Health Laboratories in Concord, New Hampshire. Let me stop sharing this slide set for a moment. You know I always like to see everyone. It's nice to put a name and face together.

So if you feel so inclined, turn on your cameras. It's nice to see you all, hello there. I would like to ask everyone a quick icebreaker question, which is already in the chat. With May coming very soon, which is your favorite outdoor activity to do as the weather warms up? I want to hear what you are excited to do during spring. Hiking, strolling, golfing.

Oh, San Francisco, the weather is usually colder in the summer. That's true. I think a place that I spent that I felt coldest in my life was in a summer in San Francisco. I wasn't prepared. Gardening, fishing. Wow, pickleball, hiking, hiking, lots of hiking. Jogging, playing tennis.

You guys inspire me. Outside in nature with the kids, awesome. I like that. Me too. I want to do lots of hiking. Thank you all for participating in the icebreaker question. Let me go back to the slide set.

All right, I guess you all can see, yes. Next. Now, I'd like to provide a brief recap from our last session in March featuring Dr. Joseph Kozlovac from the U.S. Department of Agriculture, who presented on Leadership: Roles, Responsibilities, and Authorities. We had a total of 123 participants attending the session who were affiliated with 80 organizations.

Joe spoke about leadership's role in improving biosafety and emphasized the significance of organizational culture related to this. One particular quote from a participant at this session that I would like to highlight is, quote, "We promote the idea that good ideas can come from anyone. I also have employees help with finding solutions to get by."

I think that was a great point because everybody can make great suggestions. And supporting staff to think that way and feel empowered to do that is a great thing. So during the session, Joe also conducted a case study about creating a practical plan to improve the safety culture at a medical school laboratory to mitigate safety-related events and stress the importance of leadership support.

We encourage you to share information about our ECHO Biosafety sessions with your colleagues and to connect amongst yourselves via chat if you'd like. Next slide.

Before we continue, I would like to address some technical aspects of our ECHO Biosafety sessions. 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.

Here is a brief overview of today's session. I'll introduce our subject matter expert, Michael Stevenson, who will provide a didactic presentation and a real case discussion. Then my colleague, Lieutenant Commander Folasade (Sade) 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. A few weeks after today's session, the transcript, the audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website.

OK, so I would 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. Michael Stevenson has been involved in the public health laboratory setting since 2010. He worked at the Idaho Bureau of Laboratories for over nine years in several roles, including Safety Officer and Deputy Laboratory Director. Then he joined the Alaska State Public Health Laboratories for three years as a Public Health Laboratory Scientist leading the special pathogens testing program.

In June 2022, he joined the New Hampshire Public Health Laboratories as their Quality Manager and was promoted to Deputy Laboratory Director in March 2023, where he oversees opportunity–operations– opportunities as well– but operations, quality, and safety. His undergraduate education was at Butler University in Indianapolis, Indiana, followed by a PhD in Biophysical Chemistry at Stanford University in Palo Alto, California. Michael, the floor is yours.

Michael Stevenson: Thank you all for the introduction and thank you to the ECHO Biosafety team for inviting me to participate in today's discussion. As we said, the title is Planning: Developing and Achieving Biorisk Management Objectives. So if we go to the next slide– yes, that's the same title. I won't repeat it. Sorry, next slide.

Yeah, so as part of today's discussion, we're going to be kind of involving ourselves with the International Organization of Standardization's standard 35001, which involves biorisk management system and biorisk management objectives. So I'd like to give a quick review of what the ISO 35001 standard is, discuss a pilot program that me and cohorts were involved with here at the New Hampshire Public Health Labs, and then discuss some of the outcomes from the program we were involved with the Association of Public Health Laboratories and the Centers for Disease Control and Prevention.

And that will lead to our purpose for today's discussion on risk management objectives and examples that came from our pilot program. And hope to have a good conversation with everyone on the call today on other BMOs that we could all be achieving in our lab setting.

I did want to point out, though, here at the New Hampshire Public Health Laboratories, we are applying the principles behind ISO 35001 towards lab safety in general, so including chemical safety, radiation safety, as well as biosafety. So you'll see in today's presentation examples from chemical safety, BMOs, specifically. And then peppered throughout, we're going to have some polls and group discussions through this presentation. I love polls, so we've got a good couple of them available. And I believe our very next slide is a poll.

So the poll that will pop up on your screen is, does your facility have the following full-time designated positions? And you should be able to select all that apply for you.

Great. Thanks, George. The results are in. It looks like 72% of all of our participants today do have a biosafety officer, or a BSO. About half of our participants have a chemical hygiene officer, same for radiation safety officer and general lab safety officer overall. We have a couple of others. None actually selected none for us here at NHPL because we don't have a full-time dedicated person for any of those roles.

So it's a role– it's a hat that I wear. I have an APHL fellow that helps me here in those responsibilities. And we have a safety committee here. But I was wondering if anyone would like to discuss what– whoever chose other, what are your other choices that you have that helps you with maintaining safety in your lab? Anybody feeling comfortable to want to share?

Mary Brock: Hey there. This is Mary Brock. I'm sorry, I'm at Duke University, so we have others in ergonomics and other departments.

Michael Stevenson: That's great. Ergonomics especially, that's very important for–

Jonathan Koolpe: This is Jonathan, if you can hear me, from UC San Francisco. We actually have a controlled substances officer who works in controlled substances.

Michael Stevenson: That is a really good point too. That's something we're working here in New Hampshire on, controlled substances, how we have that safety and regulations managed. Was there anyone else?

Mohammad Khan: Hey, this is Khan from UTSS. So we have a physical safety officer over here to handle all of our engineering sites, engineering labs.

Michael Stevenson: That's great. Thank you, all. If we move on to the next slide then– so yeah, just as a discussion with all of us, what gaps do you think you might have for an effective lab safety program without having a dedicated officer? Anyone having some issues or challenges that they face if they don't have a even part-time dedicated person in that position?

I could mention, while you're thinking about that, here at NHPHL, since we don't have a dedicated full-time person, I think one of the things that might suffer a little is our timeliness on trying to maintain and manage an effective safety program here. And I think it would be really of value for us to have a dedicated staff that could really focus on those objectives of ours and ensuring they're completed in a timely manner.

Aufra Araujo: So Michael, there are some comments in chat. And I won't say names, but I'll just read some of the comments. And if folks feel comfortable unmuting, they can expand. But some of the comments are, "I'm the all-in-one safety person for all these duties." Another person said compliance issues, communication is a problem. It's hard to be an expert in one area when you have to focus on all the areas. Delayed risk assessments, continuity of efforts. So yes, if anyone would like to expand on those comments.

Stacey Alexander: This is Stacey from North Dakota. I can expand on mine. So to be the biosafety officer, safety officer, the RO, all the things, it's hard to be an expert. Or you continually feel like you're dropping the ball on something when you have to wear all the hats.

Michael Stevenson: I second that, Stacey. And it's great hearing your voice. It's been a while since I've gotten to talk with you.

Stacey Alexander: It's been a few years.

Michael Stevenson: Our Northern Plains Consortium days, yeah.

Stacy Agar: And this is a different Stacy. And my comment was continuity of efforts. And what I meant by that was when you try to piecemeal a program like that and you have one person working on one thing and one person working on another, you lose that continuity that I think is important to maintain your integrity of the program.

Michael Stevenson: That's a really good point too, especially, I'm hoping, if it's a large facility too and you do have multiple people playing roles that you have your own little committee gathering on a routine basis to check in and try to keep that continuity in place. Any other last thoughts before we move on?

I will mention as a segue to the ISO 35001 standard that having a structure with a systemized process of identifying and making changes that your facility can be very helpful as well to have a success in your endeavors. So if you advance to the next slide, I want to go into a little bit of recap from previous ECHO Biosafety sessions of what ISO 35001 is.

Aufra Araujo: And Michael, before I move to the next slide, I just wanted to share something that popped up in chat just now. "At UCSF, we have officers for several fields which keeps the programs robust. For some fields, there is more than one person on the team." How awesome is that?

Michael Stevenson: Yeah, it's great we have a wide range of people on today's call. Yeah, so quick summary of what ISO 35001 is. It comes from ISO, which was established in 1947. So it's a worldwide federation of national standards bodies. They've actually published well over 25,000 standards, covering all aspects of– almost all aspects of technology and manufacturing.

The standard that we're going to pluck out of that massive number is ISO 35001, which is entitled "Biorisk management for laboratories and other related organisations." So this standard was actually published very recently, in 2019. So it took from 1947 to 2019, 72 years, to get an ISO standard published related to biosafety in a facility.

It's a relatively short standard. It's only 26 pages. And with its timely publication and the pandemic hitting right after that point, not a whole lot of movement has occurred with the standard and getting more involved with facilities, particularly with agencies that could accredit a lab to be ISO 35001 compliant. So hopefully we will start to see those accrediting bodies out there that could perform that service for us.

If anyone on the call has any information on the status of any of that, please put that in your chat. It'd be great to hear if there is an agency out there that is planning to provide that accreditation. But moving on to the next slide.

Pretty much, it defines a biorisk management system which establishes principles allowing labs to achieve their biosafety objectives. It defines the components for a robust biorisk management system framework. And it also then wants– helps to develop and implement biorisk management objectives that will help to continuously improve the biorisk management system.

And it's really set up in that plan, do, check, act cycle to help implement and monitor these changes that may be occurring at your facility as you implement ISO 35001.

So if we move on to the next slide, focus a little more specifically on what the biorisk management objectives are. According to the standard, they should be measurable. And by that, I think of the SMART objectives, which is Specific, Measurable, Achievable, Relevant, and also Time-based. They should be able to be monitored by your safety officer or a committee, checking on the progress of that objective that you've established.

You want to make sure it's being well communicated to the appropriate staff to ensure its effectiveness. And then, as part of the Plan, Do, Check, Act, also, you want to be checking in with it, updating it as appropriate, and then hopefully being successful with that BMO.

The next slide is a poll question. So yes, have any of the facilities, any of you on the call today, have you actually implemented any part of the ISO 35001 standard? Yes, no, or no, but I would like to?

All righty, and of our over 100 participants, 17% have said yes, they have implemented some of ISO 35001. But the majority would be no, have not been able to and no, but I would like to. So it's good to see all that. For those who have implemented it, if you would advance to the next slide, another discussion point is, what successes have you had with implementing ISO 35001?

Feel free to speak up or put it in your chat. And what challenges have faced when you have implemented ISO 35001?

Aufra Araujo: So while folks are entering chat or thinking about the answer, I just wanted to comment that Marian Downing put in the chat they need the ISO implementation document before the accrediting process can proceed. They are close, she believes. So she's referring to the accreditation body portion.

Michael Stevenson: So yes, if I understand then, so ABSA, the American Biological Safety Association, is planning to be possibly an accrediting body. Is that what you mean, Marian?

Marian Downing: We've proposed it, but I'm talking about the ISO implementation document. And Kalpana and Barb from Merck are involved with that. And that's been on the hob for two and a half, three years– well, ever since 2019, I guess. And I understand that it's close. And nobody can accredit, I don't think, without the implementation document.

Aufra Araujo: And that's the CSLI workgroup, correct, Marian?

Marian Downing: The ISO working group. Yeah, it's on their website. There's a little blurb up at the top about the implementation document.

Michael Stevenson: Does anybody else want to share what successes or challenges they have had by implementing ISO 35001? While you're thinking or preparing an answer, I can say for NHPHL, I selected yes for that poll because we actually did participate in a pilot program that was led by the Association of Public Health Laboratories and the CDC.

And I'll advance to that next slide to give you more information on that. Yeah, feel free to put something in the chat if you want to share your experiences. But I'll summarize what this pilot program was like. It was started in July of 2021. And in March of 2022, NHPHL was identified as a pilot site to actually implement the ISO 35001 in a public health lab setting.

My predecessor, Jill Power, was very integral with all of this pilot program that we did here at NHPHL, and she retired in– it's been over a year, so that's December of 2022. But up until that point, she was a key player in all of the aspects that we did with this. And I joined NHPHL in June of 2022, so right before we had a two-day site visit.

So Jill got me all up to speed on the ISO standard itself and what it was all about and then prepared for our two-day off site visit, which was facilitated by people representing APHL, CDC, and a contractor. And they had created a sort of checklist to address all of the clauses that are in the standard. And through discussions with our key staff here at the lab as well as visiting the lab spaces themselves, they performed an assessment on our ability to meet the ISO 35001 standard.

And that was a great experience. But of course, as they left, we realized we've got some gaps that we'll want to address. But they did formally give us a gap analysis in September of that year. And from that point on, we came up with our responses of how we would address those gaps as if we were trying to get accredited for the ISO standard. And so we began with that processing of trying to become compliant.

And then in April of 2023, the group came back again from APHL and CDC. And it wasn't another assessment or inspection of our facility. It was more a support of how are we doing with what we responded and trying to achieve goals with those gaps that were identified. So it was a really good experience. Another public health lab was also involved with this pilot program. And in the June of that year, we got to visit that lab as well to see what gaps they had identified, how they were addressing them.

So overall, this pilot program was really beneficial for us, a great experience where we were exchanging the ideas, visiting people, commiserating and supporting each other, and implementing best practices throughout. So if we advance to the next slide–

On this table, the left column is representing what ISO requirements were from several of the clauses. And on the right side of the table is what basically the gap analysis from the pilot program had identified for us at NHPHL. And the top one that I bolded was that we needed to establish and develop measurable biorisk management objectives. So we definitely have recognized that.

These other four rows were identifying some other gaps. And we kind of used those gaps analyses to create our biorisk management objectives for 2023. So that's what the next few slides will be going over. We're going to go over these four particular ones. There were others. I won't share every single one with you. But we will go ahead and address those one by one and then have discussions with all of you in terms of how you might address them as well or establish a biorisk management objective.

So if we move on to the next slide– one of the gaps we had was we needed to evaluate monitor and communicate performance of by risk management control measures. So as a discussion point with everyone on the call here, how would you go about doing something like that? Some thoughts I had put were– you probably are doing risk assessments, but more formally, would you be doing internal audits of your safety parts programs? What role would your safety officer, your quality manager be playing? And anything else that you might think about.

If anybody wants to give some thoughts, have a discussion on how would you address that gap.

Marian Downing: So Michael, this is Marian. In June, we're going to be talking about communication. And this is one of the things that I'll be talking about. But it's basically things like newsletters and team meetings, daily, weekly, to communicate what your gaps were, postings in the labs, safety committee meetings where you give lunch so people come. And then you communicate what your problems are and what you're doing.

Michael Stevenson: Yeah, those are great examples of communicating it effectively to all your staff. I see in the chat too there are, like, how one would maybe evaluate potential gaps or safety risks, safety audits. Yep, that definitely is really good. Risk assessments, having that safety officer right there on the site to do it. Yep, I like what I'm seeing from everyone.

Aufra Araujo: So a follow-up in the chat is how often. So it seems like someone said those safety audits, and somebody asked how often. Any ideas, Michael?

Michael Stevenson: Yeah, I think that would be– I see from Joyce's response– hi, Joyce– they try to hit it annually, but COVID happened. Yes, that too. I think in our case, we annually do lab safety inspections, as an example. And if there were anything egregious, we would definitely be doing follow-up to make sure that changes have been implemented.

But I think, yeah, with everyone's other job duties, just annually doing a safety audit is great. The more the merrier, but obviously we've got other duties as assigned. And 5% of that for those other duties, it's not a lot of time one can dedicate, which, again, is why it's awesome to have a dedicated safety officer.

If you move on to our next slide, I would want to talk about what we did addressing that here at NHPHL, more specifically how are we evaluating and monitoring.

Aufra Araujo: I also wanted to point out one more comment in the chat. I'm trying to summarize all the comments. But there is one, determined biosafety levels for all processes ensure policies protect at or above the required levels, documented maintenance schedules for biosafety cabinets, et cetera, and internal audits. Lots of internal audits here. And somebody else also mentioned they work with the quality manager to conduct the audits or inspections. So I just wanted to acknowledge all of those comments.

Michael Stevenson: Yeah, thank you, Aufra. And thank you everyone for your comments too. And I do agree, a quality manager should play a key role with aspects of safety. And we are lucky here. We've got two quality officers here at our facility. As she advances to the slide, this is how we were at NHPHL addressing– how we're evaluating any risks in the lab and how we would monitor them.

So we do have an Excel file– old-fashioned, I guess, but Excel risk assessment file where staff would fill these out if we are implementing a new test at our lab. Really, that's one of the requirements before a new test method would be approved to be worked in the lab is by doing a Safety Risk Assessment, or SRA, as we call them here.

And if you can see in the right side of that box are suggested risks that one would consider that would impact safety or operations, like sample receipt, sample accessioning, transporting the sample, preparing them in the lab, loading/unloading them into an instrument, storing them, disposing of them, chemicals involved as well with that test method and how you're handling your chemical waste, and maintaining safe housekeeping activities– if janitors are coming into your lab during business hours or after business hours, that it's a safe environment for those janitors to come in.

But as I said, yeah, we have an Excel file. And so each row of the file would be an identified risk. As I show you in the example here, like, receiving the sample, you would describe what that risk is. What steps would you do to mitigate the risk? and any other comments you'd like to provide. And then you can also rate that with the likelihood and consequence of that risk. And then with this file, we can generate it on a heat map. And we've seen that before, where you don't want to be in the red area. You might would want to consider other mitigation steps that could reduce that risk to be a more acceptable risk if it can get down into the green area.

And we do use Qualtrax– formerly Qualtrax. It's called Ideagen Quality Management now. But it is an electronic document control system here. So we do upload all of our SRAs into Qualtrax for approval. And then we do have them expire annually. And then that author then will be prompted to review the Excel file and make sure there have been no changes. If the method itself has been changed, they want to be able to address that in the SRA and have it reviewed again by the actual testing staff.

So once it's officially published, all the testing staff would review this SRA and be aware of the identified risks that could be occurring in the lab with this particular test or test platform, if you choose to go more generally. If there is anything from the chat you'd want to mention, Aufra.

Aufra Araujo: Yes. So there is a question. Where do you indicate that a new test must have a risk assessment first? Is it in the QSM?

Michael Stevenson: It is part of an SOP we have for what we call method implementation. So it's an SOP where we designated that as a requirement. We actually have a checklist of all things that must occur before a test would be approved to be performed in our lab.

And that includes having a validation or verification plan, having a report, all those approved, having the SOP written, doing the safety risk assessment, ensuring the staff are trained and have demonstrated competency, having all of our LIMS, Laboratory Information Management System, codes ready for that, have our test menu updated. And the list goes on. But yeah, we do capture that in an SOP.

Aufra Araujo: And another question is, how do you get people to give enough details about the task?

Michael Stevenson: I'm not quite sure what the question is asking. When we do safety risk assessments, it's not just one person who uploads it to Qualtrax for approval. We have a meeting together with all the appropriate staff, including the supervisor and some of the testing staff. And we have a general discussion on each of these identified risks.

And more is verbalized as opposed to what gets captured on the Excel file, per se. But I think it's effective for us though, if that helps to answer the question in the chat as well.

Aufra Araujo: I guess, unless the requester would like to unmute and expand on the question.

Andrea Vogel: That was my question. I think you answered it, but it was kind of– I was asking, if somebody says they centrifuge, well, that's very broad. I mean, what are they centrifuging? Are they centrifuging with the buckets that have the aerosol tight. Are they centrifuging in BSCs? So I was just wondering how you get people to give the types of details so you can make the assessment.

Michael Stevenson: Yeah, we would provide more details than a very general statement because, yeah, that won't be effective for the other testing staff who will need to review this as part of being trained on it. But yeah, you're right. We would be saying things like that. A centrifuge process occurs, potential aerosolization, so you will have buckets with lids. Or it would be in a biosafety cabinet as part of mitigations for that.

Aufra Araujo: Thanks, Michael. Another comment in response to that question, somebody else posted in chat was they observed the task during internal audits as well.

Michael Stevenson: Yeah, I'm not sure if that means each of maybe these identified risks that we would be capturing on the Excel rows. It could be also considered– yeah, I guess that's probably what you're meaning. You're making notes when you're doing your safety audits in the lab, Mark.

All right, yeah, if there's nothing further, then we can move on to our next example gap that we found here at NHPHL, which was that we were needing to develop and standardize a biological materials inventory from this particular clause in the ISO standard, stating that we needed one.

So yeah, just as a discussion with you all, how do you maintain inventory of your biological materials and of chemicals? Chemical inventory is also very critical in any sort of lab that uses chemicals. Other thoughts– how frequently are you performing inventory of those materials? And then, finally, do you have an inventory management system that's in place that can also encompass other aspects of an inventory like your supplies and your equipment?

Andrea Vogel: So we just made—

Aufra Araujo: Please go ahead.

Andrea Vogel: Thanks. We just created an internal wizard kind of thing. That way, labs can go in and check off which biological materials they have, suggest new ones if we're missing any. And we also have a chemical database as well on our internal servers.

Michael Stevenson: I was reading within the chat as well– RSS platform. I'm reading Jonathan's authorization for review by internal safety committees. If you are comfortable, Jonathan, do you perform inventories with any regular frequency?

Jonathan Koolpe: Yeah, we have a system of– we call it DSA environmental safety advisors, and they go inspect the labs quarterly. And they report back to either the biological group or the chemical group, the hygiene group as to what they find. So they're kind of our eyes of our program, if you will. And the labs are a very large institution. We have 700-plus labs.

So we're pretty busy. So we rely on them to let us know, as well as each lab has its own manager and to some extent tell us what they may be adding. And we do audit them as well to some extent. So it's a pretty robust program overall. It's challenging. There's so many– it's challenging because there's so many of us. There's so many labs. But we do our best.

Michael Stevenson: What is your organization that has so many—

Jonathan Koolpe: University of California San Francisco. We're fortunate. We have good support. We have good support for our safety programs. We're fortunate in that respect.

Michael Stevenson: Yeah, and academia versus commercial or a public health lab setting, there's a lot of similarities, but there's definitely big differences as well as far as academia with all the students and all the research that may be going on. Yeah, it's a much more robust process you want to have in place. Thank you. And Tanya, I'm seeing, yep, Excel spreadsheets, which isn't ideal. Yeah, that's what my next slide will be showing you is that we do use Excel again.

But we have looked into Juvare. It is something we have here for our department as a whole. But really for our staff, we never really embraced using Juvare. And we've kind of relied on Excel. And we are trying to identify going back to Juvare not only for chemicals and biological inventory but also for our equipment, our supplies how many gloves we have. If you don't mind going to the next slide because I think that's a poll. Whoops.

Yeah, if you don't mind, as an aside, I was curious– because I want to make sure– I want to represent all aspects of safety. So as you probably know, for chemicals in a facility, you need to have your safety data sheets available for the staff. It's an OSHA requirement. And I'm just curious how do people maintain all of their chemical safety data sheets. So go ahead and submit your answer, whether you just keep paper copies in the lab in binders, if you actually just have PDFs on a common drive. Do you do both? Or do you have another way of managing all your safety data sheets?

I can tell you what we do at New Hampshire is we are moving towards electronic copies only being current and up to date. Staff have options to maintain paper copies in the lab if they so choose. But we are having them all on a common drive location folder that anybody could access from a networked computer. I think in the essence of time, I might just move us right on to the next slide if that's all right with everyone.

I just wanted to show you what we were doing then for maintaining inventory at our facility. It is an Excel file. I'm showing you our very simple Excel file for monitoring all of our chemicals, where we have the green columns on the Excel file are required fields that need to be filled. The orange columns would be optional for staff to also input, but we have dedicated staff in each of the labs that would be updating this for us. We want to try to do it every two years.

And this is what we have in place right now. And I think it's sufficient for our needs at our public health lab of about 90 staff. I'll go ahead and move on to the next gap that was identified for us, if that's all right, Aufra.

Aufra Araujo: Sorry, I was having trouble muting. I wanted to share– somebody put in the chat that at Duke, they have over 600 laboratories. So each lab has their own way of doing—

Michael Stevenson: Basing that on a previous comment of continuity, too, that would be challenging if you're trying to maintain any sort of continuity. Yes, so for this next gap analysis, they suggested that we should be validating our autoclave sterilization cycles for our biowaste.

So I was just curious in a poll here, do you regularly evaluate the effectiveness of your autoclave biowaste cycles? Yes, no, no, but I want to, I have a incineration on site so not a problem that way, or some other mechanism in place.

That's very impressive. I mean, you have 67% of people do evaluate the effectiveness of their sterilization cycles. So very big applause to everyone doing that. I selected for us in New Hampshire Public Health Labs, no, but I want to. Obviously it was a gap that was identified for us. And I'll discuss on the next slide how we're doing that. But yes, if anyone who has selected other, if you would want to share another manner of how you're handling your biowaste. Let's see it in the chat.

Aufra Araujo: So I see a comment. "Most of our waste is handled by a vendor, but we have a small autoclave program which we validate the autoclaves for monthly." Another one uses vendor incinerators offsite. Those are just a couple of comments.

Michael Stevenson: Actually, that was Maureen's comment. I believe I noticed an earlier chat from you, Michael, that you work at CBR in Boston. I sure did. I don't remember you specifically, but I'm glad we connected again. Really quickly then, any others in the chat? Data logger, yeah. Yes, if you want to advance to our next slide.

This is what we are doing now at NHPHL. And this has really been a key proponent from our fellow Joe Romano, who's in the APHL Biosafety and Biosecurity Fellowship Program. So he's taking the lead on establishing an effective means of validating our sterilization cycles for all of our autoclaves here that are involving biowaste.

So we are proposing that we're going to do this annually with our autoclaves or if there was any sort of major repairs done on an autoclave. We have a representative autoclave test bag that's got lab coats, gloves, culture plates. We even throw a sharps container in. We throw tips in. We have absorbent pads in case one is dealing with a bio spill and you need to autoclave that afterwards. And our intent is to test our sterilization cycles by putting two of these bags in.

We're going to be connecting data loggers that are monitoring the temperature and pressure of the autoclave in the bag, outside the bag but in the autoclave. We're putting in biological indicators, chemical indicators. And then we're running those after to see the effectiveness of these sterilization cycles. So if anyone is going to be attending the APHL annual meeting that starts up next week, definitely stop by Joe Romano's poster that's talking about his work he's doing here for us at NHPHL. So big shout out to Joe.

I would like to– if you don't mind in the chat or anything, how much water do you add in your autoclave bag when you are going to do a sterilization? It's a question that popped up in our own heads like, oh, just a beaker full. But what's a beaker full? Is it a 5 mL beaker, a 50 mL beaker?

No water, none. Wow, OK. Yeah, I was getting the intent that water can only help. But no, I appreciate everyone's feedback on that too because I was originally thinking, no, we won't be adding water. We want to test the autoclave setting itself, the cycle, the parameters. So that might be something we'll consider again then since responses have been predominantly no water is added. Someone did add water though. I appreciate everyone's feedback on that. Thank you.

If you don't mind advancing to our next slide, Aufra. This is our last gap analysis, which was they recommended we ensure that incident investigations, corrective actions, et cetera, are monitored and checked for continual quality improvement. So I was wondering, how do you all manage that as well? How do you manage your CAPA, Corrective Action/Preventive Action, root cause analysis? In what ways are you maintaining that in your lab that involves your quality manager or your safety officer when it's related to safety? Anybody feel comfortable sharing how you manage that?

Aufra Araujo: So one common theme is that many states have autoclave guidance for decon of biowaste, including water, how to close bags, et cetera.

Michael Stevenson: Thanks, Marian. It says many states. So yeah, I'm curious if there is a link or something that you could share. I'd love to see what does– does New Hampshire have autoclave guidance? That's something I wasn't myself aware of.

If we move on to the next slide, it's a poll. I just wanted to segue to how we're kind of doing our monitoring for corrective actions and all. And we do it electronically with our Qualtrax system. So I was just kind of curious from everyone else, if you don't mind identifying if you do have a electronic document control system, what are you using?

ClickUp, I haven't heard of ClickUp. OK, it's across the board, which is great. The majority is actually other than what I had listed here. So I'm sure there's a lot more out there that I'm not aware of. I've been lucky at the three public health labs that I've worked at now– we were using SharePoint in Idaho. In Alaska, we were using Media Lab. And then we moved to iPassport. And then here at NHPHL we use Qualtrax.

And Jill Power actually recommended that I look into more of this workflow process that Qualtrax provides to electronically capture events and remove the paper format and wet ink signatures on documents. So I kind of took that in stride and really kind of implemented a workflow that I wanted to share on the next slide then on how we're monitoring incidences or quality events that occur at our facility.

I'm calling them quality improvement reports in terms of the workflow for Qualtrax. Aufra, if you don't mind advancing.

Aufra Araujo: Michael, I want to just read some of the comments in chat. So some use INSPECT. Another one uses Qualtrax workflows for internal audits and CAPAs. There is a comment here on risk management, saying daily log of incidents. If there is one that involves recombinant DNA, animals, or pathogens, their division follows up and gets more details of the incident.

They also fill out a biological incident report form in addition to the risk management form. Another one has effectiveness checks as follow-ups. Yes, several comments on their process and procedures. Thank you. This is a robust discussion.

Michael Stevenson: Thank you, everybody. Yeah, so for our Qualtrax workflow, I mentioned I call them QIRs, so Quality Improvement Reports. And it's basically not just capturing a corrective action type of event that occurred. We really wanted to capture all sorts of quality events that occur at a facility. And that's what I'm indicating on the lower left in red, what our different categories would be that we'd like a QIR to be filled out in Qualtrax.

And so like for safety issues that may have occurred in the lab or outside, whatever, we also through the workflow ask them, was this a near miss or was this an actual incident that did occur and required any sort of assistance to the staff? But yeah, we're addressing customer service even, capturing all of our drills and exercises we do here at the facility, outreach that we do to our community, to our state partners. We want to capture all of that in terms of quality events.

And as you can see from the overall flow of this workflow that I've created, you've got some metadata in the first box on your left. You're identifying then the actual event details itself about what happened, how did it happen, and then what response was taken to address that immediately. The workflow then moves it on to the quality manager to review and make them aware of an event that had occurred. And then they can be indicating other staff to be involved in this workflow, specifically the lab director.

Then there's this risk analysis and an impact that occurs where you're identifying the frequency that this type of event occurs, the consequence of the event, and then actually giving an impact to it. And then whether it's a very low or a low rating of an impact, it goes straight to approval by the supervisor, and the quality manager, and myself as the Deputy Lab Director.

If it was ranked as a medium and a high or very high-incident impact, then we do move it towards a root cause analysis, which is another step in this workflow in Qualtrax, where we're identifying what was the root cause or multiple root causes, what corrective actions are going to be taken, what's the timeline to get that corrective action completed, identifying the responsible people involved.

And then that itself then moves on to approval. In both cases, this QIR workflow instance does get approved by the staff. There's always the option to reject it because they weren't satisfied with a potential corrective action. So that moves it back to the supervisor then to address that comment and then apply more reasoning or other corrective actions in place.

Ultimately, though, the QIR event will get approved and closed in Qualtrax. And then we've got it set up that 30 days later, an email alert will pop up to the deputy lab director or quality manager to review this particular QIR to see if any other follow-ups were needed and then go forward with that as such. So this has been working really well for our staff. We've gotten a lot of great feedback from them. Previous to this, it was paper copies, writing it out, or typing it out. And then you've got your format issues too if you're trying to fill out this Word document. Then trying to get everyone's signatures on it– we're very happy to have moved away from the paper version of all of this.

And I think this is great too in terms of doing the annual quality management review. And at least in Qualtrax, you can do a report on all the QIRs that occurred in all of the red categories that I've described. And it just makes our annual QMR much easier to summarize for all of our staff and our external partners. So we're very happy with how this is working for us.

Would anyone else like to make any comments based on using an electronic process or any other thoughts regarding in general on capturing incidences and corrective actions?

If not, then I think I'd like to begin just wrapping up then by asking people what would they consider to be good biorisk management objectives that you would be implementing at your facility? My last slide will be on what we're planning for 2024, even though we're already officially at the end of April, four months in. I was going to show you what we're planning to do. Why don't I go ahead and, if you don't mind, advance. And that might prompt other people to put in the chat or feel free to talk.

But yeah, we're wanting to make sure all of our chemical safety data sheets are all electronic in this common drive folder. We did do our annual lab safety inspections, and we were fortunate to get a good chunk of money from a grant to implement improvements based on those inspections. So our goal is to implement all of those and use up the money that we received to have a safer working lab.

I mentioned Joe Romano is working on our autoclave sterilization process. That was a biorisk management objective we had for 2023, and we're carrying that into 2024 to wrap that up and then have that in place for us. And then another one, update all of our spill kits for bio spills, chemical spills, and perform spill drills with our testing staff and make sure everyone's comfortable addressing the spill that occurred in the lab.

COVID really derailed a lot of the general safety measures we had in place. And so this is kind of restarting now since things have luckily calmed down again. Any other thoughts on what you might consider for a biorisk management objective?

Aufra Araujo: I think while people think about that, there is a question in the chat, Michael. Do you have any metrics that you measure?

Michael Stevenson: Regarding any of the BMOs that I've shown you? Metrics to measure– I know, that's a good, smart way of choosing your objectives. I think I'm looking at here on 2024 just having the autoclave sterilization validation. We've submitted a plan already. And now we're waiting to finish all of our data collection, write up the report. Joe has already written up the SOP. And then we're going to be doing this validation for all of our autoclaves here and their sterilization cycles.

So that's a measurable– just getting it all done by the end of the year. Same for getting all of our spill kits updated by the end of the year and performing spill drills in our lab settings.

Aufra Araujo: There is a comment in chat from Jill that if any lab has ISO 17025, they need to create quality objectives. So it would be ideal to add some safety objectives along with them to assist with improving the safety program.

Michael Stevenson: Yeah, good suggestion. At our lab, we have quality objectives set up for 2024 for pretty much all of our testing sections as well as having safety objectives that I've got on the slide here. But yeah, there's definitely more that can be captured. I just want to make sure we can stay smart on them so we can be successful at the end of the year and move on to other objectives for the next year.

Aufra Araujo: Then Marian put some resources in chat talking about the EPA regulations are very detailed and difficult for many entities to follow. They were drafted with the help of waste management company. And she put in the chat there are ways, SOPs, that would have to address the addition of liquids, amount of water, closure of biohazard bags, et cetera. And there is a– she put a link in the chat.

Somebody else also commented. "Our incidents are low, and we continue to adapt our program to ideally maintain this low number by following up diligently for any incidents that do occur."

Michael Stevenson: Yeah, thank you, Jonathan. Thanks, Marian, for the link. Job safety assessments, annually, huh?

Aufra Araujo: One more. "We have a job safety assessment annually where we perform risk assessments and ensure protections from the risks that are established for job tasks. We do this for laboratory employees, office staff, warehouse workers, et cetera." Yeah, great comments, discussions.

Michael Stevenson: That's really good also, yeah. That is what I have to present today. You can go to the very last slide, which are some of the resources I used, almost all from APHL. They've been really key to help me in their publications, especially for creating a quality improvement report workflow. I was very much excited to read their nonconforming events documents. And I definitely appreciate the Wadsworth Center in New York supplying us with their validation SOP for sterilization cycles. It's been very helpful to us as well.

That's all I have. And I really do appreciate everyone's talk, the chat, your participation today. So thanks for your time.

Aufra Araujo: Yes, that was an excellent discussion. Thank you, everyone, for participating. Thank you, Michael, for your excellent presentation and sharing our experience with the audience. Now, I will invite my colleague Sade Kembi, who is a Health Scientist in the CDC Division of Laboratory Systems to provide a summary of the discussion.

This is a tough challenge for Sade because it's a huge discussion with many, many great topics. Sade, you have five minutes.

Folasade Kembi: OK, thank you, Aufra. Good afternoon, everybody. So as Aufra said, this is really a robust discussion, but I will try to provide a summary. So Michael started by talking about how many designated safety officials we have in our labs.

So from the poll, most laboratories have full-time designated biosafety officers. However, they don't have dedicated personnel for other offices such as radiation or chemical hygiene officers. Some biosafety officers have to do everything. And because they have to do everything, they cannot be an expert in all areas.

Some of the disadvantages mentioned, if you have designated people for different areas, is communication may be a challenge. Planning may also be a challenge. Then, continuity of the process may also be a challenge when you have dedicated people in each of the roles.

However, some facilities, they have officers for several fields, and that keeps their program robust. Then we also talked about how many laboratories are already implementing the ISO 35001. 17% have started implementing it. 44% have not, but they would like to.

And one of our personnel pointed out that they will need the ISO implementation document before the accrediting process can proceed. But then we can always start the ISO project even before the documentation. The documentation will just be for accreditation.

So some of the successes that they have experienced in New Hampshire, according to Michael, because they have participated in the pilot program from the APHL– so they identified gaps in their program. And because they identified the gaps, APHL and CDC were able to provide support in identifying the gaps and in addressing some of the gaps.

And because of this, they were able to collaborate with another lab and who is also engaged in the pilot program. So that led to a very successful implementation of ISO– even though they are still working on it, but at least they have advanced. Then he posed some of the questions to other people and how they have also addressed it.

One of the questions is how to evaluate, monitor, and communicate biorisk management or other safety control measures. So some of our colleagues mentioned that they use newsletter, daily meetings, posts in the laboratory, safety committee meetings where lunch is provided, effective communication, risk assessment, safety audits, documentation of internal audits, and documentation of maintenance schedule. I think that is very important.

And in New Hampshire, according to Michael, they work with quality managers. Then they also use Qualtrax for documents control system. Somebody posed a challenge that some organizations may not have enough people to give enough details about tasks that are required in Qualtrax. But then somebody also tried to answer the question that you observe the task during your internal audit and you document them.

Another person also mentioned doing risk assessment separately on instruments. Michael also posed another question about maintaining inventory system, both, of the biological and chemical inventory. There's an organization that uses RSS platform for their BUAs and chemical inventory.

And another organization uses Excel spreadsheets, even though they mention that this may not be an ideal situation, but that is what they are currently using. And they are looking for ways around it to better their inventory system.

There was also a question about maintenance of chemical safety data. 42% of our colleagues, they use electronic copies, while 41% use both electronic and paper copies. 11% uses paper, and 6% uses other.

Then how do we evaluate– how do you do our evaluation– that is, evaluation of effectiveness of our autoclave system? So some use a vendor. Some have incineration on site. And some of the people that validate, 67%. And 12% said they don't validate.

So New Hampshire, they are currently working on doing annual validation using, both, biological and chemical indicator. And the question was also asked how many people add water. Most people recommend that we don't have to add water. Just one organization said they add 150 mL. Somebody said we can follow the guidance in our different states.

We also discussed how to ensure– we also discussed how to ensure incident investigation, root cause analysis, and corrective action. And some of the suggestions are you contact the biosafety officer, who contacts the person that is involved. And they discuss it and document it.

Some people use their risk management system that send daily logs of incidents. And with that, they will complete incident forms, and they will complete a risk management forms. For document control, 13% use Qualtrax. Some people use iPassport, which is 12%. Media Lab, 17%. SharePoint, 19%. Some people don't use anything, while some people use INSPECT, CAPA MasterControl.

We all just use different things for documents control. But New Hampshire, they create electronic workflow to document and monitor quality events. So the last thing that was discussed was biorisk management objectives. And New Hampshire based this on the inspection that they have had.

So there are various management objective that they are currently working on. It's to ensure completeness of chemical safety data sheet, to implement and update identified gaps in 2023 lab inspection, update the biological and chemical spill kits and perform spill drills, and carry over establish autoclaves realization validation procedure.

So somebody also suggested that they will do this based on their job safety assessment. So this has really been a good discussion. And I hope we have all learned from it. Thank you, over.

Aufra Araujo: Thank you for your terrific presentation, Michael, and the summary, Sade. Also, a big thank you to all members of this biosafety community of practice for participating in the discussion today. Now I would like to talk about the post-session survey. And at the end, I have a little "gift," quote, unquote. So stay till the end.

In the chat is the link to the survey for today's ECHO Biosafety session. So please, this link will take you directly to the Qualtrax survey. This survey should take no more than two minutes to complete. Your response will be anonymous. No unique identifying information will be sought or kept. And the feedback we receive will be summarized in aggregate only. Your participation is voluntary but is strongly encouraged so we can continue improving the ECHO Biosafety Program and achieve better outcomes with this community of practice.

Before I move on, I'd like to give Michael an opportunity if there is anything he would like to add.

Michael Stevenson: Nope, I'm all talked out. So I find that successful.

Aufra Araujo: Thank you, Michael. We appreciate everyone's 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 or discuss during the ECHO Biosafety session, please reach out to us at dlsbiosafety@cdc.gov.

So let me go to the next slide. We are excited to have our next session on Thursday, May 30, at noon. So please note that this session won't be during our regular day, which is the last Tuesday of the month. But it will be on a Thursday at the same time, noon.

The topic of discussion will be Support: Resources, Competence, and Awareness presented by William Pinard from Sandia National Laboratories. As a reminder, you can access the transcripts, audio recordings, and presentation slides from previous ECHO Biosafety sessions on the DLS ECHO Biosafety website. Today's presentation will also be posted there in a couple of weeks.

Before we close out today's session, I would like to make an announcement. As part of the Division of Laboratory Systems' commitment to biosafety and biosecurity, DLS is offering free access to the International Organization for Standardization ISO 35001 2019 standard, entitled "Biorisk management for laboratories and other related organisations," which is what Michael spent his presentation talking about.

The offer is currently limited to interested laboratories and organizations within the United States. The standard was first published in 2019, as Michael mentioned. And it enables an organization to effectively identify, assess, control, and evaluate the laboratory biosafety and biosecurity risks inherent in its activities.

It defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. It is suggested for the use of laboratories that test, store, transport, work with, or dispose of hazardous biological materials.

And here is how my "gift," quote, unquote, how you can request. DLS requests that institutions wishing to gain access to the standard within the U.S. designate a point of contact to facilitate the process. Your POC will initiate the access request and assist in distributing access within the institution.

So this is how the process works. George will put in the chat how you can request. And so you have the instructions there and all the details. This initiative aims to streamline the process and ensure that DLS has an organized list of individuals interested in receiving the ISO standard within each organization. So follow the instructions in the chat.

DLS recognizes the importance of this standard in enhancing biorisk management in laboratories and encourages your institution to participate. So if you have any questions, please contact us at dlsbiosafety@cdc.gov. With that, we will adjourn. I look forward to seeing you next month. Thank you for attending today's session. And I hope you are intentional about having a safe and fantastic day.

Additional resources and related publications

• International Organization for Standardization. (2019, September). ISO 350001:2019: Biorisk management for laboratories and other related organisations.
• Association of Public Health Laboratories (2021, October). Public Health Laboratory Model Practices for QMS11-A: Nonconforming Events.
• Association of Public Health Laboratories. (2022, June). Improving Biosafety in Our Nation's Laboratories.
• Chester S. (2023). Piloting the ISO 35001:2019 Standard. APHL Lab Matters.
• Centers for Disease Control and Prevention. (2024, January 26). 01/26/2024: Lab Update: Access to ISO 35001:2019 – Biorisk management for laboratories and other related organisations