Support: Communication and Documented Information

Transcript

Date of session: 06/25/2024

Facilitator

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speakers

Marian Downing RBP, CBSP, SM(NRCM)

Independent Biosafety Consultant

mmdowning1@gmail.com

Domenica Zimmerman

Independent Biosafety Consultant

deezimmerm@gmail.com

Aufra Araujo: Good morning, good afternoon, 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 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 sixth Extension for Community Healthcare Outcomes, or ECHO, Biosafety session for 2024. The topic for this interactive discussion is Support: Communication and Documented Information. Today's subject matter experts are Marian Downing and Domenica, or Dee, Zimmerman, who are independent biosafety consultants from Texas.

Let me stop sharing these slides for a moment here and this way, we can see everybody on the screen. Let's see, I have an icebreaker. You know, we love icebreakers here. So I'd like to ask everyone a quick icebreaker question, which is already in the chat.

What's one personal or professional goal you have for the second half of the year? This time, keep entering your answers in the chat. But in the interest of getting to know each other, I will start by calling on someone to unmute and respond, and then, that person will choose the next person. So feel free to also put your answers in the chat while we do this. So let's see somebody here, randomly – Stacy Agar?

I see, "More biosafety seminars," but would you like to open the mic and share a little bit more where you are calling from? Oh awesome!

Stacy Agar: Here I am. Hi, Dee! Nice to see you again.

Domenica (Dee) Zimmerman: Good to see you, Stacy.

Stacy Agar: I'm in Virginia, and I wrote, "More biosafety seminars." That's probably why you called on me a bit. But there's so many options out there for all of us as we're trying to learn more about the field and follow what other people are thinking and what other people are reading. And so, I love these. I love the APHL, Marian, as well. Those are awesome. And so that's my goal is to try to learn as much as I can at the whole rest of the year with these seminars. So thank you for providing me.

Aufra Araujo: Would you like to just randomly pick somebody and call on somebody to share as well?

Stacy Agar: Yes, randomly. I will pick James Pharr.

Aufra Araujo: And whoever is called, if you were unable to turn on your camera, feel free just to unmute, that would be great. If you can turn on the camera, too, of course.

James Pharr: Hello, everybody! Sorry about that. I was having some difficulties with – I'm not as familiar with Zoom as I am with Teams these days. But in terms of personal or professional goals, our team is expanding. So I'm hoping to find a couple more biosafety professionals to add to our team as we grow into a brand new research building.

Aufra Araujo: Awesome. And where are you calling from, James?

James Pharr: Sorry, I am in Philadelphia. I work at the Children's Hospital of Philadelphia.

Aufra Araujo: Awesome. Yes, thank you. It's great to have you here. Would you call on somebody else?

James Pharr: What about Rolinda Bailey?

Rolinda Bailey: Can you all see me?

Aufra Araujo: Not yet.

Rolinda Bailey: Okay, let's see, let me see if I can. Yeah, I've had some trouble.

Aufra Araujo: It's okay. We just, oh, there we go! We can see you now. Hi, Rolinda!

Rolinda Bailey: Hey, everyone. So I put in the chat, I am very excited to announce that I will be retiring in October. So a very smooth transition for whoever is fortunate to become the biosafety officer here at the Tennessee Public Health Lab. That is my goal. Also working on a couple of big projects – revision of our COOP plan and our lab-wide safety manual. So those are the big things I have on my plate, so a lot to do between now and October.

Aufra Araujo: Wow! Thank you. Thank you for sharing that with us, and congratulations on your planned retirement.

Rolinda Bailey: Well, I hope to still do some part-time work. But thank you so much, thank you.

Aufra Araujo: Thank you. Would you like to call somebody else? Last person.

Rolinda Bailey: Oh, let's see here!

Aufra Araujo: Randomly.

Rolinda Bailey: Randomly.

Aufra Araujo: Yes.

Rolinda Bailey: Let's say Kayla Borton.

Aufra Araujo: Let's see if Kayla – I don't hear Kayla. It's okay, maybe she's unable to speak or turn on the camera. It's alright.

I see a personal goal here, this is Jonathan: "Find affordable homeowners' insurance." Yes, good luck. ABSA main conference in Phoenix. Oh, I hope I can be there too. Awesome. Thank you so much, everyone, for participating. That's always fun to get that face-to-face contact with most of you, whoever is able to. So let me I need to share the screen again. Let's see if this works. Yes, you all should be able to see my slide? Good.

Alright now, I would like to provide a brief recap from last month's session in May. It featured William Pinard and Allison Treloar from Sandia National Laboratories, who presented on Support: Resource, Competence, and Awareness. William and Allison discussed resources, certifications, and training programs related to the ISI 35001 standard, which is biorisk management for laboratories and related organizations. This slide shows a particular quote from a participant in that session. We had a total of 104 participants attending the session, who were affiliated with 59 organizations. The map on the right shows where these participants are located. The states shaded in green had participants from at least one organization. Also in attendance were participants from 6 national organizations and organizations located in Belize as well.

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.

Before we continue, I'd 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 will introduce our subject matter experts, Marian Downing and Dee Zimmerman, who will provide a didactic presentation and discussion. Then my colleague, Dr. Mary Casey Moore, 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 today these slides contain presentation material from speakers outside who are not affiliated with CDC. So presentation content from external speakers may not necessarily reflect CDC's official position.

Now, it's my pleasure to introduce today's presenters:

Marian Downing is currently a biosafety consultant. She has 50+ years of laboratory bench and biorisk management experience in public health, academia, pharma, and veterinary laboratories, and retired after serving as a Biosafety Officer at Abbott Laboratories. She is a past president of ABSA International, the ABSA representative to the APHL Biosafety and Biosecurity Committee, and Co-Chair of the Emerging Infectious Diseases Committee. Relative to this presentation, she was the Chair of the Inspection Committee for the ABSA International Laboratory Accreditation project.

Dee Zimmerman retired from the University of Texas Medical Branch, Environmental Health and Safety. She was the biosafety officer and director of the health, safety, and training core for the University of Texas Medical Branch (UTMB) Galveston National Laboratory. She was the senior environmental health and safety consultant in the Biological Safety program and served as the university's select agent program alternate responsible official, IBC member, and coordinator.

Her duties include working closely with research staff, research scientists, biocontainment engineers, facility staff, and occupational health. Dee was with UTMB from 1982 until retiring in 2017. She has been a member of the NASA Biosafety Review Board from 1997 to the present, reviewing ground laboratories and flight experiments. She attended Inter-American University in Puerto Rico and was the lab and safety coordinator for the Marine Ecology Division, Center for Energy and Environmental Research at the University of Puerto Rico. Dee is the 2019 Past President of ABSA International.

It is my pleasure to give you today, Marian and Dee. The floor is yours.

Marian Downing: Okay. So I'm going to speak first, and I'll be talking about communication. This is Marian, and I just have to say I'm so honored to be asked to present to this group. I recognize a lot of you from APHL, and I'm excited to do this discussion, which is going to focus on the ISO biorisk management standard, and also the CWA, which was the forerunner of this document. Next slide, please.

So communication is actually mentioned more than 30 times in the ISO document that we're talking about today. And as we heard from Will and Allison last month, they were talking about resources, competence, and awareness. All of these topics overlap with each other. You can't have training without documentation. You can't have communication without documentation. Everything is going to sort of overlap. So I'm hoping I don't steal anybody's thunder.

But one thing, if you're inspected by an ISO-designated inspector, when it comes to that, they're going to want to see top management commitment. And that's a big piece of the document, is how much your management is involved. And this is initially demonstrated by having a biosafety policy and a biosafety manual. And I just got the Iowa State Manual up here, which happens to be online and has a nice cover as an example of something that's available out there, that's available to anybody if you want to look at it.

And people generally, in their biosafety manual, are going to have a policy for biorisk management, and then their SOPs and other documents, procedures, and the individual labs will have the manual and then have their lab-specific documents in there.

So we want to see the policy as a commitment to a biosafety program and the things that normally are going to be in as little as maybe a few paragraphs that the institution commits to compliance with local, state, and federal regulations; maintain as safe a workplace as possible; reduce risks to the workers, their families, the environment, the community – those are, you know, the normal things that you're going to have in your biosafety policy, which is part of your manual. Next slide, please.

Another part, besides upper management commitment – this is pretty all encompassing here, and it's a direct quote from the ISO standard. "...roles, responsibilities, and authorities related to biorisk management are defined, documented, and communicated..." So Dee's stuff is part of this as well because she's doing documentation, but, "...communicated to those who manage, perform and verify work associated with biological materials."

So right there, you've said that you go to have a top-to-bottom commitment to people knowing what their roles are – the management, the supervisors, the quality folks, anybody who oversees their work, the workers themselves – that they understand what their job is, and what the risks are.

So one thing that ABSA is actually working right now is to update the OSHA/ABSA Alliance document that's on the left side of the screen which talks about biosafety competencies. And I've had mentees who were, you know, told that they were going to were chair the IBC. They were going to do chemical inventories, things like that like that. And it really helped to have a nice document like this, and I will say, APHL also has a competencies document, but it could be a little different than the ABSA/OSHA one that talks about what a normal biosafety officer's duties are. Now your job description may be different, that's something else. But you know, generally the biosafety officer is not running the IBC and things like that.

So as part of your communication you want everybody to know who these things apply to. You want the SOPs for disinfection, autoclaves use, waste disposal, how to use the biosafety cabinet, use of PPE, all that kind of stuff, and door signage. These are all ways of communicating with people, you know, and this would be talking also about your requirements to enter the lab. Sorry, somebody's calling me. And next slide, please.

One thing that's really useful for communicating the risks to the lab workers, which is part of that previous slide, is starting with a Canadian Pathogen Safety Data sheet. Hopefully, you're all aware of these, and they cover, there's 100 of them, and they cover all the major communicable diseases so that people that are working in the lab have these in the biosafety manual for the organisms that they're working with or likely to be working with. And that's part of their training/communication.

Also, it's recommended that laboratory employees actually sit on the Management Safety Committee, and as members of the Biosafety Committee, the IBC. If you don't have a point of view from someone who's actually working in the lab and handling the equipment and dealing with the risks you may have, you know, folks on some of these groups, the IBC or management actually, who haven't worked in a lab and don't really understand what the risks are. So that's a good place to start.

You should have this training, as we said, on modes of transmission, PPE, pregnancy and immune suppression risks, because that's something that's a little bit anonymous. I've been to a number of places where they had a policy that the pregnant or immune-suppressed individual was supposed to report to their supervisor with those issues. That is not how that would be handled. Usually it should be anonymous, and they should talk to a medical provider. So you have to look at your SOPs and your training for immune suppression in pregnancy.

And then the other thing that overlaps with training and competency and documentation is the BMBL, the Biosafety and Microbiological and Biomedical Laboratories. Hopefully, you're all familiar with BMBL. At BSL-2, the lab supervisor has to ensure that laboratory personnel demonstrate proficiency in standard microbiological practices and techniques. And that's pretty straightforward. How do you ensure that? And how do you document it? And how that, you know that's all part of communication that people are actually trained and able to fulfill that requirement. Next slide, please.

So the first poll question is, "How does your institution ensure that the root causes of biosafety incidents are communicated without identifying..." Well, this is poll number two. Sorry you got poll number one, George.

Anyway, it's going to say, "How do you ensure that a worker demonstrates proficiency?" And I know how that was done in pharma, but in my experience, many universities, maybe some public health labs, clinical labs don't really have anything in place to make sure this happens.

So do you have a hands-on, 3 or 4-step process with a trainer? I've got the model over there on the left. It could be 3 steps where you demonstrate, and the trainee asks a lot of questions, and the second step is they do it and ask questions while they're doing it with the trainer overseeing it. And then the third step is, they do it themselves, and they do it competently or not. And each of these steps obviously could take more than one time.

Do you just have a manager or supervisor observing? Do you work with a mentor? And that mentor approves the employee training or competency? So maybe a co-worker rather than a manager or supervisor. Do you have a written test? Maybe it's a piece of equipment that you actually have to know a lot of the fine points for.

Do you quiz? Do you have something in writing or verbal quiz after you train somebody, or is there some other way that you're doing this competency assessment?

And if you would like to, and I'll just say here, these are talking about documentation. But where I was got my feet wet, if it wasn't written down, it didn't happen. So if you're doing a 3-step process with someone, you're actually documenting the day, the time the employee what you covered, and you know, the different sessions that you've had with that person, all documented.

So, looking at this, it looks like manager and supervisor observation is the most frequent, and then co-worker or a trainer are pretty much the same. Written tests, maybe that's at the end, and then the quiz. It's interesting, I just want to emphasize hopefully, you have some way of keeping track of when and who does this, and who makes the decisions about whether someone's competent or not.

Anybody want to volunteer anything about this? How this works in your lab or something else. There's 4% that say "other." I'd like to hear what those are if you would unmute. Anybody? Okay, we'll move on.

But the take home from this is if you're smart, you're going to document all of this in writing. Okay, next slide.

So communicating the goals of the biorisk management program. BRM being biorisk management. And up in the in the corner, I just threw that in there again. Do you have a written biosafety policy? That was something we're looking for when we were doing our ABSA accreditation visits, that you have something in writing about what you're committing to.

And how are those objectives that are in the policy and in the biosafety manual – how are they communicated? Are they – first off, they are communicated, and then the topics, we already talked about some of this. Compliance with laws, reducing waste, protecting the environment. You know, maybe you talk about incident reduction or making sure people are reporting, as we know, that people don't report everything.

Do you have a whistleblower policy defined somewhere? What your expectations are for emergency response and improvements to the risk assessment process. The diagram on the left is just to show this is what's in the free ISO document that you can lay your hands on. That's a summary of the ISO standard. It relies on the Plan, Do, Check, and Act model. And this diagram sort of simplifies the process to ensure people understand the needs and expectations of interested parties, which is stakeholders, I assume. You know, you got to make sure that you're talking about everybody that could be exposed to this material. And it's got to be written down – the plans and the objectives. Next slide, please.

So communicating the goals of the program again. One of the main major things in the ISO standard is regular performance evaluation. And we're not just talking employees here, we're talking the program itself. How often labs are visited and evaluated, how often training is taking place, whether it's changed or not. Are the SOPs reviewed on an annual basis? Do you have a date of review even if there's no changes? You're looking at incident trends. These are all part of the performance evaluation beyond lab inspection and individual performance evaluation.

They want to make sure that you're communicating to anybody in the organization whose work may be affected by the biorisks. So right there, you're talking about waste handlers, emergency personnel, security, facility engineering, occ health, contractors who are in the area. Upper management is maybe starting this process, and it's not just laboratories. We have to make sure that we're inclusive of anybody who may be handling these materials and be exposed to these biorisks and reviewed by relevant leadership. So you know, this stuff is approved by the leadership, they have to understand what the implications are if you change things.

One aside is that we started, years ago, doing employee performance evaluations to include safety factors. So we were having problems getting employees to wear safety glasses which were required by the SOPs, and so we could enforce that with a performance evaluation point. And this actually was pretty effective for getting people to pay attention to what was required. Next slide, please.

Internal and external communications are determined. So what we tell people inside the organization and what we tell people outside. We want to talk about and put in writing what will be covered. So in far as far as communications. So we got the biosafety policy, we've got the expectations for the organization, basic lab operations, very important. Spills, exposures, illnesses, what the expectations are for this communication.

And then about that information in the first bullet, when this information will be communicated to employees, maybe to NIH if it's recombinant involved, state and local authorities after diagnosis of disease. And be aware, you know, some people, maybe on the webinar today, aren't working with recombinant material and aren't really too involved with the NIH, but you've got a immediate phone call when you have an incident involving recombinant material. And then you've got 30 days to file a report that you put together after an in this investigation. And I saw that Kathryn Harris was on. I'm sure she could talk about this for days.

But I was at one institution, and this applies to the next bullet. Who is going tell anybody about this stuff? We had the PI call NIH, and we also had the biosafety officer call NIH, and they hadn't talked to each other, and their notifications on the day of the incident were not totally in agreement. So your best case is to have this all written down about – Kathryn's chatting about non-disclosure. Yes.

So your best case before anything happens is to have this all in writing about who's going to do the investigation. Who's going to make the initial phone call, and who's going to follow up and write the final incident report. And we're just talking NIH here. We could also be talking about select agents.

Sometimes it's the IBC chair. Sometimes it's the BSO, could be an EHS lead. The principal investigator who may not have the big picture, unfortunately. Could be a chair of the compliance, or the manager of the compliance department. There's a number of people who could be involved and you want to have it in writing ahead of time of who that's going to be.

You also need to be aware of local required notifications for reportable diseases, such as TB, to the local public health lab. So if you've gone to the hospital and been diagnosed in a hospital, then usually they would notify the public health lab. But if you have doctors in the occupational health, they need to be aware that these require notifications, perhaps. And then you got, as I mentioned, your select agent notifications for the Select Agent Program and other organizations that may want to be notified. Next slide, please.

Okay, so we talked a bit on the last slide about incidents and somebody, you know, sticking themselves with a needle, or you know, whatever the case might be. How does your institution ensure that the root causes of biosafety incidents are communicated, obviously without identifying those involved by name, with lab staff? So how do you make sure that somebody who does something that maybe wasn't such a good idea.

And as an example, years ago, had somebody that needed a lot number off of a vial that was in a sharps container, and this person reached into the sharps container to pull out a vial and stuck themselves with a needle. Nobody knew what was on the needle. They had some thoughts, but it wasn't definitely for sure. And so, how do you communicate something like that with your staff to make sure that this isn't a practice that they're doing? Do you do it in annual training? Do you do it in bloodborne pathogen annual training? Do you have a newsletter? You send out some kind of computer blog or notice to your lab folks? Or is there another way that you communicate when you find something going on that's maybe not so great.

So we have annual training and an annual bloodborne training sort of close. I want to mention here just my own personal opinion. A lot of places I've been to, they use the same bloodborne pathogen video for 10 years, and there's nothing relative to the institutional incidents or stuff that actually has happened where you're working. So you need to figure out some way to include incidents and responses and things like that in your annual bloodborne pathogen training if that's all you're doing.

Computer notice and biosafety committee meeting minutes. Okay, yeah, I'm hoping people actually read those, but can you pull up some of these other chat things, Aufra? I saw a huddle, Anna had talked about a huddle. That's great if you're having huddles a couple of times a week or every day, and then you make sure that you distribute that information to everybody. It's not just, oh, you know, this guy over here did something not so smart the other day, and you make sure everybody is aware that that's not a good practice, obviously without mentioning anybody's names. Okay, sounds good. Next slide, please.

Alright, and then who are you going to notify? And we've already talked about NIH, select agents, your public health department. But you've also got other people, like your local folks. And internally, you've got the laboratory staff, you've got safety, quality, legal, and public relations. One of the IBCs that I'm on, we have public relations and legal at most of the IBC meetings. Externally, this IBC has promised transparency with the local community. How do you ensure transparency so that the folks in your town aren't reading about something in the newspaper, or – can you go back, please? They're not hearing about this from the newspaper, but you've already notified the community liaisons and you've already talked with the legal and public relations folks in your organization if you have them. And your local police and fire may be involved. So in writing, you should have this communication written down who should be notified about what kind of incidents or problems you're having.

And then we've got news outlets and watchdog groups that will find out. You may have somebody in house that's talking to people. If you have some kind of an incident, a spill, a leak a flood, electrical outage, power outage, the building goes down, the negative pressures not working, things like that outside folks may find out about. You need to contemplate in advance and have it written down what you're going to do about that.

Sorry I couldn't hear that. Okay, how to communicate – so is it going to be verbal? You're going to make a phone call? Or nonverbal – you're going to put up signs. You're going to send out blurbs or emails or texts or newsletter. You know, a formal letter, I've seen that happen for outside organizations to notify them of some change or something that they would be interested in that's going on.

And the other thing here I wanted to mention from my own past was the communication with maintenance with a BSL-3 area where we were doing large-scale production. You know, we had maintenance guys in the elevator pushing buttons with their screwdrivers. And you know, they obviously either didn't believe what we were telling them or hadn't had enough training.

And then, one time, there was a gentleman working in a construction area inside the BSL-3, and it had been decontaminated. His head cover came off, and he put it back on, and he touched his head as he put the head cover back on in this deconned area, and then he went home and took a shower, and then his daughter took a bath in the bathtub.

And Monday morning, I got this frantic phone call from this gentleman about whether his daughter had been exposed to HIV, which is what we were working with. And this was despite training on modes of transmission survival in the environment and all those kind of good things. Obviously, he had worried about it all weekend, it was sort of sad. But you got to make sure that you're training people that are not going to understand unless you do some training for them. Okay, next slide. Here's a poll question.

So the first one is, "Do you have a written procedure for any mandatory reporting of incidents or spills?" And by written procedure, I'm talking about who does what and the time involved. And you know everything's written before you have to address this. So that's a yes or no.

And the second one, "Does it include a clear explanation of timing, who is responsible for investigating, who makes the actual phone call or sign the formal submission, and who will follow up on the incident?" So if you could answer that poll, that would be good.

Oh, wow! So there's a lot of folks who have a written procedure for reporting, but not everybody has all the details written in advance.

And you know, this is something you can get your IBC involved with as well. It's just like an IBC following up on noncompliance. It's you know, good to know in advance what the IBC thinks should be happening in these situations–as far as who's going to call it, could be the IBC chair. Especially if it's a recombinant material. So something that you want to think about maybe putting in writing. If you don't have that all listed out. Okay, next slide, please.

Okay, so yeah, more communication. It's effective. It's not just communication, but it's effective communication, and that's hard to measure. Thank you, Kathryn, we don't want NIH chasing you down.

Yes, so, as I mentioned, I unless I'm wrong, it's still immediate for an incident. That involves a potential or a pretty sure exposure. And then 30 days for the final follow-up. So the next in communication is about the information security program.

So your biosecurity for your computers. You know, one thing that's come up in some of these IBCs is the freedom of information parameters. What are you going to be able to report or exclude from your minutes. You need to talk about that within the realm of what NIH wants to see–exposed worker. Confidentiality for incidents. Let's see.

Make sure that the employees are instructed about computer security. Do you have something in writing about whether they can take their work computers, their personal work computers, home. Who has access to them? Data, confidentiality. That was a big deal in pharma even 20 years ago, and I'm sure it's even more now because of industrial spies and things like that. But in public health and clinical lives. You want to make sure that you're maintaining confidentiality for people's names, and anybody that's been, you know, involved with testing and who they are.

Two-way communication is important, so do workers have access to the most current info, and do they also have a way to express their concerns without being punished? If they have something (they either have maybe a box, an anonymous tip box) that they can say if they don't feel comfortable telling their boss what they're not happy about. Do they have an employee safety committee meeting where they can speak up about these things? So it goes both ways.

And the picture there on the top is a newsletter from what's covered up here. UWM. So there are lots of folks who have news newsletters and things like that. Next slide, please.

And getting towards the end of my stuff here. We want communication for the significance of the program. And that's people that we've talked about stakeholders. And do you do annual training, even if you don't have changes? That's always a good way to keep in touch and keep your finger on the pulse of what people are unhappy about or worried about.

Obviously, didactic training is a lot less than it used to be. But it's a good way to find out what's going on with people than just having them do online training. As Will mentioned, regular lab inspections are a good awareness communication route that you can not just tell people you got to fix that; you got to tell them why; maybe tell them what regulation you're referring to. And why, it's important.

Fire police, local public health departments, other emergency responders are in the loop. We will have training with them hopefully. If they have to go in labs with microbes listed on the door. Are they comfortable, or are they scared to death? So they need some awareness of the organisms you may be handling in those areas that they might have to go into.

And then, as I mentioned, everything is in writing, you've got documentation of your safety meetings, your minutes and including upper-level management in any discussions–and then also people reading SOPs and changes to SOPs and things like that.

And now we're going to hear from Dee about more about ISO expectations on documentation. Thank you for your time.

Domenica (Dee) Zimmerman: Had to unmute myself. Hi, everybody! Marian has really brought out the role of communication and documentation, and keep in mind that they're integral. Without documentation, you can't have communication. And without communication, you can't have documentation. It is inclusive and very integral.

One of the things I wanted to mention is that the structure has to be embedded in your entity or institution. It needs to be a top-down process. Documentation should start with your upper management. And it can be something, depending on your organization, as simple as a written statement from upper management that's incorporated into your biosafety program. And I very much encourage a written statement with a signature because it really speaks to an inspection agency that there is a commitment from upper management.

And as part of that is ensuring that your legal or upper management reviews to ensure that what you place in your documentation is appropriate for the state or country you are in. Sometimes, we can get carried away with things and don't realize that we may be treading on other regulations. And these groups can very much help you determine what is appropriate within your state and country regulations.

Documentation drives all the way down into your laboratory. And that includes research protocols. This is really hard to get across in laboratories, that how they're performing on a day-to-day basis needs to be documented and laboratory staff should be signed off to ensure that there's a standardization across the lab. Documentation allows this to happen. Next slide, please.

So the extent of documented information can differ, and it can differ by the size of the organization, the legal, the complexity of the organization, and the competence of persons. And this is where documentation can help you.

As Marian talked about communicating and training, especially on the competence of persons, helps a great deal. And as you bring in new staff, and you've identified core people that will put their eyes on that person and ensure that they are following the standardized documentation and being signed off—really completes that biosafety loop. Moment here as I...

So it's very, very important that whatever documentation you produce actually is what's going on in the laboratory. You can have a beautifully written document for a biosafety program, but if it is not reflected in the support of upper management in the actual day-to-day process within the laboratory, that documentation is nonexistent. So keep that in mind.

When you put together your documentation. Don't be the only person working on it. When we talk about risk assessments, we say, if you, as a biosafety person, are the single person creating that risk assessment, what you are providing is simply an opinion. So make sure that you put together a group–a peer group–that works together to create your documentation. Because if your documentation doesn't reflect what's happening, then you have a problem, and the complexity of your processes. It becomes much more critical that you have documentation, and there are signoffs.

When it comes to the biosafety manual, when you're developing one, updating one, there's absolutely nothing wrong with going out to other biosafety professionals and finding out what they're doing. Most of us will share our manuals, our biosafety policies and procedures. Just keep in mind that they're not transferable verbatim, and sharing is very central to the biosafety profession.

But we are unique. And if you have one biosafety management program, you have one biosafety management program. We're not necessarily cookie cutters. So keep that in mind.

Make sure that you document the validation of your competencies. So again, your documentation provides the standard step-by-step procedures for your documented competencies; that way you make sure that anybody coming in understands what the documentation is, and they sign off on it.

How do you figure that out? A lot of times, it's that interaction with people on a day-to-day basis. If they understand the documentation, if they have a question, they should be coming to you.

I had a situation where a research laboratory I was working with, we were having some back and forth about some of their biosafety procedures and their need to kind of step up and get to work on things. And we worked on a couple areas they needed some help on. And I didn't hear from them for a while, and then one afternoon, sheepishly appeared their principal investigator. And he was working on a grant.

And this particular grant required a letter of compliance for biosafety, and the realization that his dollars depended on how competent he was within the realm of biosafety was a plus. He realized that this was integral to what he was doing in the laboratory. And I had a lot better relationship with him after that. So keep that in mind. Next slide, please

Creating and updating. Make sure that you have review and approval for suitability, accuracy, and adequacy. And that you review approval for suitability for public release work with your public relations group. Keep in mind that as you develop, one of the areas that we tend to forget is, how do we interact with the media. And if you have a public relations department, it's a good idea to work with them, to develop some general statements for the type of work that you're doing.

So that they have something when media hits that there is a statement there that can be released, so that, there's information going out. Media understands that you're working on something with the caveat that more information will be forthcoming here.

When you're reviewing for suitability and adherence to documentation for biosafety, don't be backed into a corner by somebody that walks into your laboratory or into your training process that says, "You know, I really don't need to do this because I have 35 years of experience." That can be actually really frightening, because you don't know how much of a cowboy that particular researcher has been in his 35 years, and it's going to take a lot of communication of your documentation to ensure that they understand that this is part of the overall process that you're creating a format for them. And it will help them in the long run. Next slide, please.

Poll question number four. "What department's been identified as a keeper of your documents?" And who has the authority to update and make changes to your SOPS, your policies, your biosafety manual? And also to your investigation and root cause analysis documents? This is really important.

So wow. Do we have results?

Aufra Araujo: We are having some technical issues launched the response. Perhaps people could enter in chat, and I see some colleagues, entering some response. Let's see.

Now, they are just saying, I see EHNS. Okay, so I see some responded. I'm looking at the lot, the results here. Office of lab safety, EHS, QA, safety leadership, QA with input from other departments. Quality assurance, EHSO – those are some of the responses for the first part of the question. And then, okay, do you want to discuss that part first, Dee, before I proceed to the biosafety manual?

Domenica (Dee) Zimmerman: No, I think this is – we're good.

Aufra Araujo: Okay, so for the biosafety manual, I see office of lab safety, EHS. IBC, biosafety, EHS, BSO. A lot of EHS here. That's for the biosafety manual. And accident investigation and root cause, so some comments. Office of lab safety, EHS, and IBC–similar to the previous one, QA, safety leadership, EHSO. Yes, very similar.

And in chat, I see folks entering accident investigation and general collaboration on all these documents is the goal. Yes, lot of comments in the chat.

Domenica (Dee) Zimmerman: Excellent. I think at this point we can go on.

Aufra Araujo: Okay.

Domenica (Dee) Zimmerman: So control is incredibly important. It needs to be adequately protected. If all your, especially your biosafety manual, should have something on the cover that is appropriate and informative to whoever holds a copy of it, be it a hard copy, be it a digital, that it is protected and not shared–unless you're comfortable with somebody leaving the institution taking that information with them and sharing it. In most cases in biosafety, we're very comfortable with sharing, but we like to know where it goes.

The other thing is, it needs to be adequately updated. So it reflects the most current policies, procedures, and plans. And this is really critical. When you have laboratories that are changing in their responses and their procedures, that it's reflected back into the documentation. They have to agree. They have to support each other. And that's really important. Okay, next slide, please.

So distribution, access retrieval based on risk on what is critical. Storage and preservation: How long are you going to hold a document in your archives? In some cases, such as in the select agent program, you are defined out how long you're going to store preserve information. If you don't have that, then you need to ensure that it's written down right down to how long do you maintain accident, investigation, information.

If you're involved in occupational health and serum banking, how long do you maintain serum? That particular information should be part of your overall biosafety management program.

Also, a way of designating revisions and revision controls. It should be delineated in some way in, say, your biosafety manual—date, draft, interim, final, and then note so noted, and retention and disposition in some cases, after three years in one day, you're going to get rid of stuff, because after a while it mounts up.

I was to be quite truthful, when I retired, I was amazed at what I had maintained and even keeping that in mind that we had, you know, a three-year timeframe and getting rid of. We kept three years and one year. And it depended on the size of your program. That can be a huge amount of paperwork. So keep that in mind, retention and disposition. How long are we going to keep it? And then, how are we going to get rid of it? Very important. Next slide, please.

Poll number five. Okay. Do we... Aufra, do we have, is our poll working? Oh, yes.

Aufra Araujo: Yes, it looks like for question number one: How does your organization track training on SOP and policy, etc., and revisions? Most responded, either "computer" or "paper copy." And some replied "other." I don't know if people want to open the mic or share in the chat what they mean by "other."

Domenica (Dee) Zimmerman: That would be interesting.

Aufra Araujo: And if you'd like to discuss any of these, Dee, any further comments?

Domenica (Dee) Zimmerman: No, I think we can–unless somebody is willing to share an "other."

Aufra Araujo: Dependent on change, I saw in the chat. Dependent on change, notification only. Read and understand or instructor-led training. Oh, that's their "other." Okay.

Domenica (Dee) Zimmerman: Okay.

Aufra Araujo: And then for question number two, "Do you require training (documented reading/understanding/application) of a revision to a control document?" Most responded, "change only," "entire document," or "neither." So I'm curious if anyone would like to share about "neither" or "other." That would be interesting to hear as well for question number two.

I don't see anything in the chat. And finally, for question number three. Would you like to comment anything on his question number two, Dee?

Domenica (Dee) Zimmerman: No.

Aufra Araujo: And then for number three: Are your SOPs and biosafety manual controlled the same way as policies? Majority said yes. And 25% said no. Nobody replied not sure. Okay.

Domenica (Dee) Zimmerman: Okay.

Aufra Araujo: So okay.

Domenica (Dee) Zimmerman: Then let's go to access. This is really critical.

Access implies a decision regarding the permission to view documented information only, or the permission and authority to view and change. So within your institution, you need to designate who views the documented information, who gives permission for that documentation to be shared, and the authority to change the documented information.

What you don't want is multiple people making changes. So work with an IBC. If you, if you don't want to go the IBC route, I strongly encourage putting together a multi-person peer group that can work together, and then a designated person makes the actual changes.

When that person retires leaves, then that peer group exists, and an additional person can be designated. So keep that in mind–how that documentation is controlled, updated, and shared, is very critical.

The other part that documentation helps us with is that it creates a broad understanding across your upper administration all the way down to your laboratory worker. So that if something happens, your documentation gives them a pathway. For example. if somebody was potentially exposed, say, by a needle stick or a spill outside of primary containment, that your documentation reflects step by step procedures. And how this helps is, it really integrates to the response all the way down the road.

And if somebody deviates from that response, and I'm talking about willful deviation, then you can go back to that documentation and say, "Okay, here's what you should have done. You were trained on this. Now, what direction do we take?" And I can honestly say, there have been times when I have actually slid that information across. When someone was granted access, they were, they met with me, and we went through a document that they signed off on. And they read, understood, and would abide by that biosafety manual.

And in one case I had a laboratory that was working with an animal model. There were two of them in the working, and one got stuck. The other person said, "Okay, I'm stepping up. I'm taking over. You leave the laboratory. Notify. And I'll notify while you're leaving and you're doing 1st aid so that we can start the process."

Well, instead of leaving the laboratory, she went into an adjoining laboratory and started washing cells. And we had a biosafety person waiting for them in the change room, and we couldn't figure out where the blazes she was. And so we went into the laboratory, and here she is, 30 to 45 minutes later. Had not done her first aid, had not followed through on the procedures for exiting the laboratory. And once we got her to employee health and got all that paperwork done, then it was a question of it was an accident, and life happens.

However, there had to be some repercussion, because there was a procedure that she was trained to follow, that she willfully made a decision, which she should not have done, that it was not an issue. And pushed back the occupational health response. And so it took sitting down with her and sliding across a piece of paper that she had signed off on that, said she understood the incident response procedure.

So it was documented how she was going to do it. And she responded that she had read, understood, and would abide by. And so it took a discussion with her PI. How do we drive this home? And he said, for this particular person, we pull her out of the lab. We pull her out of the lab based on the fact, not that she had the incident, but that she did not follow the documented protocol. So documentation works in a numerous amount of ways to help support.

What was the repercussion? The repercussion was that she was removed from the laboratory for a month. She had to redo all her competency training before she was allowed access again before she was granted access. And in our institution access to the laboratory was granted by biosafety. So she could not be granted access, and this is documented in the Biosafety Manual and supported by upper administration.

And one other instance to share is, when I realized that we were ingrained was when I found out that we had a new PI coming in and going through training, and he kept putting it off, putting it off, and then all of a sudden, he was compliant. And I thought, You know this is great. He's compliant.

And then I found out from the laboratory director that he had come to the laboratory director and said, "I don't want to do this. I don't need to do this. How do I get around biosafety?" And the laboratory director told him, "You can't get around biosafety. This is what you signed in for."

And so he decided he was going to go to his department chair. And same question. "How do I get around biosafety?" And the chair told them, "I can't get around biosafety. I follow biosafety. Therefore, you have to do it."

And that's when I realized we are ingrained–that it's throughout the process that says, this is something you cannot go around. You cannot sidestep. It is ingrained in a culture of biosafety. And really what your biosafety management program does through communication and documentation is, it creates and supports the safety, the culture of biosafety within our organizations.

And when a PI comes to you and asks the question, when you become integral to what they're doing, even in pursuing grants, they understand the role that we play in. And that is extremely important. Okay, next slide, please, Aufra.

This is just out by ISO. Neither Marian nor I have had a chance to really look at it, but just to let you know that this is out. They have issued the competency requirements. And so this will actually help us in measuring our current competencies and what we might want to make changes and work on. Okay, next slide, please.

These are our references that both of us have pulled upon. So they're there for you and the last slide. Thank you so much for your patience, and Marian and I are here to answer any questions you might have, I think. I turn it over to you, Aufra.

Aufra Araujo: Yes, thank you so much, Marian and Dee for your excellent and informative presentation. And now, we open the floor for any questions, ideas, suggestions, additional discussion points from the audience. So I'm looking in the chat to see if there are any comments. I don't see anything just yet.

So feel free to unmute if you'd like, or enter in the chat whatever is most convenient. "Who issued the ISO competence doc?" Do you know, Marian? Do you want to talk about it, Dee? Who issues, I believe, is ISO itself. I don't know.

Marian Downing: Yeah, I think it's ISO and that TC 212 is the working committee, I believe. And we're also waiting on their implementation document, which has been in the works since 2019 or 2020 when the other document, the initial document came out. So that's why there's really no implementation document for the ISO standard. But there is one for the CWA, and that's listed in the references. And that's what you can use for implementation. It's going to be, we assume it's going to be pretty close.

Aufra Araujo: Alright. So let's see, I think. There are no other questions I will. Oh, there's some comment here. "Have you ever had employees sign off as having read and understood documents purposely by insubordinate to their supervisor, and when the issue was presented to them, have them state that they didn't understand?" Have you ever experienced anything like that, either of you, Marian or Dee?

Domenica (Dee) Zimmerman: I think the example I gave of the researcher that went off and washed cells, she knew what she was doing was contrary, and it was willful, and since for me we would meet with them individually, there was a discussion about the biosafety process procedures, and especially on incident response.

And you know, it's after we pulled her out, and we did retraining, and she sat down with us in biosafety, we felt comfortable that we had driven our point home. But out and out, I mean, they've been through training, and that's the advantage of communicating training. And your biosafety procedures is that when they're granted access, they understand. And if they've signed off that they have read, understand, and will abide by, all you can do at that point is, take it for granted that whatever happens is willful, and technically in my case, we could literally remove them from the laboratory, and that was it, never really had to do that.

Marian Downing: And I would just say, when I was in pharma the practice for most documents was, you only had to read the change. So you know, you could have 10 changes a week to some document that you were subject to, and maybe it's six or seven words in each. Well, that's not always what it takes to actually understand.

So if it's something important, you know, you might want to have them read the whole document if it's not a hundred pages, but signing off on five words in the middle of a document, it can be a little bit problematic, but they just don't have time to train on every document for every change. So you got to decide what's critical and what's not.

Aufra Araujo: Alright. Thank you so much again, Marian and Dee. I'd like to invite my colleague, Mary Casey Moore, to share to summarize the discussion that occurred during today's session. Mary, over to you.

Mary Casey-Moore: Thank you, Aufra.

Today our session was rich with input on the topics of communication and documentation–highlighting the collective knowledge and practices within our group.

During our communication portion, we learned that for ensuring proficiency in microbiological practices at BSL-2, the majority of the institutions utilize manager or supervisor observation. It was also mentioned that annual competencies with technical lead was also used

For root causes of biosafety incidents, majority communicated to all staff through annual trainings. However, there were other methods of ensuring transparency and collective learning that were shared, such as monthly safety meetings. This one was mentioned multiple times in the chat. Safety infographics, sharing meeting minutes and also the state of Maine Health and Environmental Testing lab shared their workflow, stating that the chief of operations will send an email regarding the near miss. Safety committee meeting will present the case, and the annual training for the bloodborne pathogen is then updated.

Lastly, there is a significant number of institutions, about 95%, that have written procedures for mandatory reporting of incidents or spills. However, we saw that not everyone had clear explanation of the responsibilities of the reporting process. So it was noted to keep this in mind when looking at your own procedures, as well as timelines for reporting, depending on the agents of which your institution works on.

During our documentation portion, we discovered that the most common department identified as the keeper of documents was the Environmental Health and Safety Department. And I also want to highlight that one of the comments stated that collaboration on all the documents is truly the goal.

Interestingly, training requirements for document revisions differed; some required training for just a specific change, others for the entire document, and there was quite a few indicating neither in a small percentage that said there were some other approaches.

And lastly, a majority of you control SOPs and biosafety manuals the same way as other policies ensuring that consistency across documents. We just had a question-answer session, where we talked about other various inquiries, such as new ISO standard, and also the repercussions of incidents where an employee might sign and say they understand, but in reality not fully understanding. And it was mentioned that it was up to the institution to really define what was critical to understand and implement the right ways to make sure that training is given

So overall, today's discussion really highlighted the importance of effective communication and thorough documentation, especially in biorisk management, and we appreciate everyone's active participation in the polls and chat.

Marian and Dee, would you like to add any additional details about the discussion points that I may not have covered?

Marian Downing: I just want to – I put it in the chat offers for those of you that are looking for ABSA Credentialing Maintenance. Aufra's going to mention it in a minute, so don't hang up just yet.

Aufra Araujo: Alright! Oh, go ahead! Go ahead!

Domenica (Dee) Zimmerman: No! I was just going to say, go ahead.

Aufra Araujo: Once again. Thank you so much for your terrific, terrific presentation, Marian and Dee, and for the summary, Mary. Also, big thank you to the to all members of this biosafety community of practice for participating in the discussion today.

As it was already mentioned, now, I would like to talk about two post-session surveys. The first is the June post-session survey regarding today's session. The QR code on the slide and the link in the chat will take you to this Qualtrics survey. This survey should take no more than two minutes to complete. Your response will be anonymous, and so 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 strongly encouraged so we can continue improving the ECHO Biosafety Program and achieve better outcomes with this Community of Practice.

Today's session is eligible for 0.125 ABSA Credentialing Maintenance points. Once you complete the survey, you can take a screenshot of this post-session survey submission page, which will serve as your certificate of attendance for the session.

The second survey is our six-month follow-up survey, which will be sent in mid-to-late July. This survey will ask you to provide feedback on the ECHO sessions you have attended throughout this year thus far, collectively. This survey is different from the monthly surveys because it focuses on gauging or use of the information provided in previous sessions and identifies factors that helped or hindered your use of the information.

We appreciate your time in completing these surveys. If you have any questions about either survey, the ECHO Biosafety sessions, or if you have a laboratory biosafety challenge you'd like to present during the ECHO Biosafety sessions, please reach out to us at DLSbiosafety@cdc.gov.

Now, as many of you will be on summer vacation in July we'll take a brief break in July, so our next session is scheduled for Tuesday, August 27, at noon Eastern time.

The topic of discussion will be Operations: Planning and Maintaining, presented by Dr. Esmeralda Meyer, who is the Director of the Institutional Animal Care and Use Committee at Emory University.

As a reminder, the transcripts, audio recordings, and presentation slides from previous ECHO Biosafety sessions are available on the DLS ECHO Biosafety website, and the slides from this session. Today's session will be available, and all the resources on our CDC ECHO Biosafety webpage, as well, in the next few weeks.

With that, we will adjourn. Thank you for attending today's session. I hope you are intentional about having a safe and fantastic day. We look forward to seeing you again in August. Have a safe and happy summer! Bye.

Additional resources and related publications

1. European Committee for Standardization. (2012, January). Laboratory biorisk management – Guidelines for the implementation of CWA 15793:2008.
2. European Committee for Standardization. (2011, September). CWA 15793: Laboratory biorisk management.
3. Centers for Disease Control and Prevention. Guidelines for Biosafety Laboratory Competencies. MMWR. 2011 Apr 15; 60.
4. Association of Public Health Laboratories. Biorisk Management for Clinical and Public Health Laboratories.
5. International Organization for Standardization. (2019, September). ISO 350001:2019: Biorisk management for laboratories and other related organisations.