Quality in Biosafety – Session Materials

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Date of session: 10/31/2023


Aufra C. Araujo, PhD

Centers for Disease Control and Prevention


Didactic Speakers

Jill J. Power, MS, M(ASCP), CMQ/OE(ASQ)

Former Deputy Director, New Hampshire Public Health Laboratories


Aufra Araujo: Good afternoon, good morning, and good evening, everyone, and Happy Halloween. My name is Aufra Araujo, and I want to extend a warm welcome from the Centers for Disease Control and Prevention in Atlanta, Georgia. I’m a PhD Health Scientist in CDC’s Division of Laboratory Systems. Thank you for joining our tenth Extension for Community Health Outcomes, or ECHO, Biosafety sessions. The topic for this interactive discussion today is Quality in Biosafety.

Today’s subject matter expert is Jill Power, former Deputy Laboratory Director of New Hampshire Public Health Laboratories. To foster a sense of community and facilitate networking among biosafety professionals, we encourage everyone to turn on their cameras during today’s session. We understand that it may not be feasible for everyone, so please feel free to join with or without your camera.

Our aim with the ECHO Biosafety Project is to connect names with faces and view the community of practice. So let me stop sharing for a moment because I want to have enough room on the screen to see all of you when you do turn on your cameras.

Hello, everyone. I’d like to ask everyone a quick icebreaker question. For Halloween this year, what costumes are you or your children wearing? Feel free to unmute or write in the chat if you prefer.

I’m a witch. I love being a witch, so God knows what that means psychologically, but hey. What about you all? Baseball player. Let’s see, what else?

Oh, sorry, Laurel, your husband has COVID, so no Halloween night outside. OK, trailer park mama, Spider-Man, witch, and ninja for the kids. I like witch. He is a dinosaur. Oh, that’s cool. I see three folks attending. Oh, nice. From the same camera, hi, everyone. So nice to see you all.

Awesome, angel, I like that. There was one year I was an angel, long, long time ago. That’s cool. Well, thank you for participating in the icebreaker. Let me go back to the slide. But you can keep your camera on if you like. Let me share back again. Is it sharing? OK.

All right, 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. 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. How do these ECHO sessions differ from other presentations or seminars? These sessions are different from regular webinars in that the main feature is the discussion of cases or biosafety laboratory challenges. The subject matter experts aim to share some applicable solutions that can be implemented in your individual laboratories.

Our goal with the ECHO is to bridge gaps, build community, and enhance biosafety. 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 expert, Jill Power, who will provide a didactic presentation and real case discussion. Then my colleague, Sabrina DeBose will summarize today’s presentation. Closing comments and reminders will follow this. And we will adjourn the session.

Today’s session is being recorded. If you prefer not to be recorded, please disconnect now. Closed captioning is provided for this session. And you can find the link in the chat box. After today’s session, the transcript, the audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website.

Now it is my pleasure to introduce today’s presenter. Jill Power is the former Deputy Director of the New Hampshire Public Health Laboratories in Concord, New Hampshire. She is a clinical microbiologist who served as the Biosafety and Quality Coordinator and worked to increase and maintain a safe and secure workplace. Recently, she supported the implementation of the ISO 35001: Biorisk Management for Laboratories and Other Related Organisations standard at the New Hampshire Public Health Laboratories.

As a certified Medical Technologist, Jill has also worked in clinical laboratories in hospitals and medical clinics, either as a generalist or a microbiologist. Jill is a Certified Quality Manager and Certified Auditor with the American Society of Quality (ASQ). She was the chair of the New Hampshire Public Health Laboratories Safety Committee, a former member of the APHL Biosafety/Biosecurity Committee, and a member of the Granite State Quality Council and the ASQ Granite State Chapter. In 2022, she received the APHL Leadership in Biosafety and Biosecurity Award.

Jill holds a Bachelor of Science degree in Medical Laboratory Science from the University of New Hampshire and a Master of Science in Management from New England College. Jill, the floor is yours.

Jill Power: Oh, well, thank you very much, and welcome, everybody. Thanks for being here. Yes, I’m the former Laboratory Director because I retired earlier this year. But I’ve still maintained my relationship with APHL and still working with biosafety. So I hope you enjoy today’s presentation.

We’ll be talking about integrating quality and safety, especially biosafety into your laboratory. I’ll be defining the ISO 35001 standard. Its pilot project with APHL, CDC, and some public health laboratories, as well as discussing tips, tricks, and challenges around integrating quality and safety. And I’ll also be talking about some quality tools that you can implement into your laboratory. So next slide, please. Can I have the next slide, please? The next one. Oh, next one as well.

So this is a poll of what accrediting or licensing bodies that your laboratory may use. It’s guided by or mandated to follow. So if you could please select all that apply. The choices are CLIA, ISO 17025, ISO 9000 or 9001, ISO 15189, the Federal Select Agent rule, CAP, TNI (the NELAC Institute), and others. You can place that in the Zoom chat please. And then none if you don’t see that you are aware of any that your laboratory complies with. And take a few minutes to do that, please.

I’m afraid I can’t see when people are done. Here we go. So the majority of you have CLIA, some have ISO, the two ISOs. Oh, nice. And a lot of you have CAP, who do probably your CLIA inspections. OK, well that’s good to know. And I’m happy to see some of the ISO standards there too. Great. All right, so next slide, please.

So quality in biosafety. What is it, and why do we care about it? Well, quality can be identified in many ways by many different audiences. One thing is certain, you know when it is lacking. Quality is a subjective term that can either be the characteristics of a product or a service and its ability to satisfy the implied need, or it’s a product or service free of deficiencies depending on where you work or your use of quality items. In biosafety, having a sound quality system can ensure you are continuously trying to improve safety practices within your workspace and processes for yourself, your staff, the work you are performing for your communities and for the environment. Next slide, please.

Integrated quality and biosafety practices in the laboratory directly contributes to a better distribution of safety outcomes, along with increased employee satisfaction. Some tools to use for integrating these in your lab would be looking at your organizational structure. What are the positions of safety officer and quality manager? Do they report directly to higher management?

Integrate safety and safety responsibilities and duties into position descriptions. This assures staff understand their role in keeping the lab safe. Evaluation of incidents or exposures and reviewing what went wrong brings quality and safety together. These two areas of responsibility should learn to work together. When there are safety infractions, quality management staff can help identify root causes, assist with setting up monitors or objectives, help train staff on how to measure these incidents, as well as help with the implementation of improvement activities.

So at this time, I’d like you to come off mute or use the chat to describe how your organization is structured for your quality and safety. Do they work together? Is it one person? Do they talk to management? Are they part of management? So if you wouldn’t mind just putting that into chat, that would be helpful.

Quality oversees biosafety. And a lot of them work together. All right, so let’s go to the next slide, please. Thank you for those who put some information in there.

So the next few slides, I’ll go over a few helpful quality improvement tools. So first, we have what’s called DMAIC. And that’s an acronym pronounced DMAIC and Lean Six Sigma. So Lean Six Sigma is simply a process for solving a problem. It consists of five basic phases using the DMAIC method.

The first one, the D, is define, where you first define your problem. M is for measure where you review or map out the current process. Analyze, A, finding the cause of the problem. I is to improve, where you’re implementing solutions and verifying their effectiveness. And C is control where you’re maintaining the change or change is made.

Lean by itself is a way of thinking about creating needed value with fewer resources and less waste. And Six Sigma is a way of improving processes by using data and statistics to eliminate errors and defects. Used together, they complement each other. Lean accelerates Six Sigma, delivering greater results from what would typically be achieved by Lean or Six Sigma individually.

In the lab, your quality control is a form of Six Sigma using the data presented to assure quality results. Combining these two methods gives your improvement team a comprehensive tool set to increase the speed and effectiveness of any process within your organization, resulting in increased revenue, reduced costs, and improved collaboration. Next slide, please.

So this is Lean. Lean training teaches you how to reduce waste and increase efficiency for your organization by using many different tools and techniques. I don’t have time to go through all of them. But many of you may be familiar with some, especially root cause analysis, which is the investigative tool used to find the genesis of a problem, and one that you use in risk assessments. 5S is the tool used to clean up and standardize a workstation, a supply cabinet, or your documents.

Gemba is simply walking around the workspace to observe how the work flows and how work is performed. And that’s important when you’re setting up a new laboratory or a new safe space. It is a way to gather information through observation and interaction with others, with your workers.

And I highly recommend it if you have the chance to take any Lean training and implement it, your safety environment will greatly improve. And I know a lot of state agencies do offer lean training, so you may want to look at your education bureaus or training bureaus to see if they offer that. Next slide, please.

So this chart is called a RACI chart. And this is a tool that could help to align your safety committee responsibilities. It’s called a RACI chart. And the acronym stands for Responsible Accountable Consulted and Informed. It’s used primarily in project management projects to outline who is responsible for what activities. I find it helpful to define, especially if you have a team that’s not sure what they should be doing, this will help align those projects or processes.

So the responsible person is the person who carries out the process or task and is responsible to get the job done. The accountable person is the one ultimately accountable for the process or task being completed appropriately. And responsible persons are accountable to this person. The consulted is for people not directly involved with carrying out the tasks but are consulted to achieve the goal and maybe someone vested in the process or task or is a subject matter expert. The informed are those who receive output from the process or task or who may have a need to stay informed.

I filled it out somewhat, but by no means represents any reflection of any lab safety committee that I’ve been involved in. But going across the top of the chart, you’ll see the designated titles, the biosafety officer, chemical officer, lab director, et cetera. And I’ve also put in the quality manager.

So going down on the left are the duties or assignments that need to be met. And this is something you as a team can decide to do. Under each key position is where the person falls in the process. So for example, if you look at the responsibilities of the biosafety officer, you see that they are safety trainings, they review the SOPs, investigate safety incidents, assure risk assessments are done, and that BSL training is done. And the deputy lab director is either consulted or informed, as well as the quality manager, and so on.

To further have staff understand their roles and safety in the lab, you could fill this out together and then have everyone sign off on it. Next slide, please.

So the overview of ISO 35001– and you’ll hear some people say it 35 O-O-1. It’s not wrong. They’re numbers, not letters. But I’d like to review the quality standard for biosafety that is called ISO 35001: Biorisk Management for Laboratories and Other Related Organisations. And it looks like organizations is spelled incorrectly, but this is the French way, or the European way of spelling it, excuse me.

The ISO stands for the International Organization for Standardization. Again, it’s a remix of the letters due to the European standards, which is an ISO is an independent nongovernmental international organization. Through its 165 plus members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant international standards that support innovation and provide solutions to global challenges. In 2019, there were 22,500 national standards. That’s a lot of work.

The number identifies each particular standard or discipline. An international standard is a document containing practical information and best practice. It is often described as an agreed way of doing something or a solution to a global problem. Its headquarters is in Geneva, Switzerland. And this particular document was published in 2019 and is 26 pages long. Next slide, please.

So when they create these documents, they use a lot of resources. And the foundation of ISO 35001 is the CEN workshop agreement documents, CWA 15793, and CWA 16393. So you can look these up for information. But you’ll find them basically all in this new ISO standard. Next slide, please.

So the requirements, excuse me, for biorisk management system (BMS) is primarily to reduce the risk in lab activities. It contains the process to identify, assess, control, and evaluate biosafety and biosecurity concerns. It is globally applicable to any laboratory that works with, stores, transports, and/or disposes of hazardous biological materials.

It complements existing international standards for laboratories. It uses the plan, do, check, act, PDCA, principle. But however, to date, there’s no accrediting body to provide lab accreditation. But we are looking into that. Next slide, please.

So the standard defines the biorisk management principles that enable laboratories and related facilities to achieve their biosafety and biosecurity objectives, defines the essential components of a framework to be integrated into a laboratory or other related organizations, overall governance, strategy and planning, management, reporting processes, policies, values, and culture. It describes a comprehensive biorisk management process that mitigates biorisk and provides guidance on the implementation and use of the standard where appropriate. Next slide, please.

So I’m just briefly going over all of these. I just want you to be aware of what it offers. So these are the overview of clauses in the standard, which most every standard has these. And so there’s a scope, which defines the process working with risks associated with hazardous biological materials, has no known normative references, because it’s the first one of its kind.

There are terms and definitions. There’s the context of the organization, which is basically to establish a biorisk management system. And it contains information for leadership, commitment, policy and roles, responsibilities, and authorities. And the last, from 6 to 10, are based on the use of the PDCA cycle. And we’re going to be going into that shortly. So next slide, please. Excuse me.

This is in the document. It is a model figure. I know it’s confusing to look at. It’s a top-down pyramid view of a biorisk management system. The bottom two layers, which are the outer two layers, are the base to support the system. And this is all found in the fourth section of the ISO standard.

Section 5 is for the leadership level. And it outlines all the roles and responsibilities and commitments for leadership. 6, 8, 9, and 10 are written to follow the PDCA cycle. And section 7, which is in the circle in the middle, is called the support. And it focuses a lot around the employees and worker management, but also deals with communications, supplies, and documentation. Next slide, please.

So based on that and the PDCA cycle, which we’ll get to shortly, here are examples of questions to ask regarding the different sections. So in the upper left under the Support section, the question is, is everybody trained and competent? And these are just things that you would look at for your laboratory.

Are info sheets available? So that’s under the Support. And then moving clockwise, beginning with the Planning box, they ask, well, what will be done? What can go wrong? What is the likelihood and the consequences as well as the controls in place? So that sounds familiar to a lot of us. Those are your risk assessment questions.

Next, under Operations, are the controls set in place? And are they working? Are staff following the SOPs? And who is actually doing the work? Are they a seasoned employee or a new hire?

In the Performance box, what are the heading– what are the leading and lagging indicators? And this is where you review your findings and identify what is working and what isn’t. And last, in the Improvement box, it asks, what changes are needed to make the risk acceptable? Next slide, please.

So here we are with our plan, do, check, act procedure. So I have a couple of slides on this. And some of you may be familiar with it. But the plan, do, check, act, which is the PDCA, is built on the– the BMS is built on the concept of continual improvement following this cycle.

The plan part is where you recognize an opportunity and plan a change. This is when you establish objectives, programs, and processes necessary to deliver results in accordance with the lab’s biorisk management policy. For example, after an incident and upon an investigation, you would want to make a change to a process so it doesn’t recur.

The do is you test the change. You implement the process as planned to change and carry out a small-scale study. The check, the C, is to review the changes, analyze the results, and identify what you’ve learned from the changed process. By monitoring and measuring your activities and processes with regard to the biorisk management policy and objectives, results can be reported and documented.

And then the act, the A, is take action based on what you learned after checking the results. If the change did not work, you would go through the cycle again with a different plan. If you are successful, you incorporate what you learned to continually improve your processes, which in turn, improve your biorisk management system. So you use what you learn to plan new improvements, beginning the cycle again. Next slide, please.

So this is a quick example of how a PDCA was done in one laboratory. After an annual safety audit, the safety committee reviewed the highest nonconformances. And this is their action plan.

So the plan was the safety committee reviews the data from their audits and target the activity for highest impact. It was found that more training on spill cleanup was needed. So the do was hands-on spill cleanup training was planned and completed. And then the check was immediate feedback was very good from the staff. Only one subsequent spill incident occurred in their frame. And a request was made for a pre-measured container for 10% bleach.

And the act was providing a mop and a bucket with water and bleach levels marked. And additional hands-on safety training sessions were performed as needed. So it can be very simple. It doesn’t have to be very detailed. But the best thing is to remember to document everything that you’re working on. OK, next slide, please.

So you may be asking, why would our laboratory want to implement this standard? More work, right? So here’s a list of the value and benefits of this ISO 35001: Biorisk Management implementation. It achieves the highest quality laboratory science while ensuring laboratory safety, promotes a culture of scientific safety and continual quality improvement, which is always good in any lab anywhere, improves validity, transparency, and reliability of test results, ensures a reliable process to prevent, detect, and remedy laboratory mistakes, provides a systematic framework for effective program management, and it’s cost-effective, benefits from investments towards assessment and prevention will outweigh the costs of failures.

So next slide, please. So now I’d like to talk about the APHL and CDC collaboration project to implement the standard. Next slide.

So APHL and CDC promoted the implementation of the ISO 35001 to develop a strategy provided guidance and support the implementation and use of a biorisk management system in accordance with ISO 35001 in public health laboratories. The goal was to improve processes to reduce incidents, accidents, infections, and illnesses that may result from lab operations and to collaborate.

So these two organizations, as well as with pilot public health labs– it’s a mouthful– excuse me, the implementation project began in July 2021 with APHL and CDC establishing a cooperative agreement. A webinar was held describing the standard, the benefits of an implementation, and the resources needed to accomplish an accreditation. In March of 2022, two pilot public health labs were identified along with a contractor to assist to perform a gap analysis and site visit in June and July of 2022.

So using a checklist derived from the standard, site visits and assessments were done on each lab. And the findings were presented. And New Hampshire was one of those laboratories. Next slide, please.

So I want to share a little of the New Hampshire experience. We had our assessment. And here’s an example of a nonconformance found using their checklist that they created. And it was the lack of having biorisk management objectives as outlined in the ISO 35001 standard, under the heading 6.2, where it states, biorisk management objectives and planning to achieve them. So this is similar to those of you who have used 17025 where you have to have quality objectives.

In this standard, though, it states that the biorisk management objectives shall be consistent with the biorisk management policy, which we had, be measurable, if practicable. Take into account applicable requirements, be monitored, be communicated, and be updated as appropriate.

So we did have quality objectives because we did follow ISO 17025. So we felt it was easy enough to incorporate safety objectives. We just had to think of small wins to get us started. We employed SMART objectives that were specific in activity, were measurable, achievable, realistic, and timely. Next slide, please.

So just an overview of, what is a SMART objective? The letters to the word SMART are actually an acronym for successfully planning your objectives. Specific is the S. And it means well-defined, clear, and unambiguous.

Measurable, with specific criteria that measure your progress toward the accomplishment of the goal. Examples would be length of time, percentage, or statistics. Achievable meaning attainable and not impossible to achieve. Realistic, meaning within reach, realistic and relevant to your labs purpose. And timely, meaning with a clearly defined timeline, including a starting date and a target date. So next slide, please.

All right, so by not having biorisk objectives, the New Hampshire Public Health Laboratories took a few other nonconformances and turned them into continuous quality improvement objectives. So here are three examples of nonconformances found in the public health lab, along with the lack of having the biorisk management objectives as outlined in the standard.

The nonconformances found were there was no reporting system for drills, exercises, and incidents that were consistent. They were documented by certain parties, but they weren’t consistent. There was no standardized biological and chemical inventory system. And no autoclave sterilization validation procedure was found.

So right now, I’d like to pause for discussion. Now that I’ve gone over what SMART objectives are for these nonconformances, I’d like for you to try to come up with some SMART objectives on any one of these. You can do all three. You can do one. You can do part of one.

But let’s say it’s January 2023, and we need to make these nonconformances into SMART objectives. So use the chat or unmute to create a SMART objective for each of these. Anyone can start anywhere. You don’t need to follow or complete an objective, just discuss what might work for one, two, or all three of them. So we could–

Aufra Araujo: Jill, while we wait for folks to think a little bit about it, about the question you asked, I was looking at chat. And I saw that Michael Stevenson shared that starting tomorrow, that you have an APHL fellow to help with safety to better distribute the quality safety responsibilities on key staff.

So yeah, that’s excellent. Thanks for sharing that, Michael. Would you care to open the mic and expand on that a little bit? We’re putting you on the spot.

Michael Stevenson: Yes. Hi, I don’t think I have anything more to elaborate on. I think this is an evolving APHL fellow responsibility when he starts tomorrow and how we can always have a quality oversight on safety but try to distinguish the two responsibilities a little bit more than how they currently been since Jill, herself, retired a little bit of time ago. Thank you.

Aufra Araujo: Awesome. Thank you, Michael.

Jill Power: So does anyone want to take a stab at any of these? One of the key ones for the second one was no standardized biological and chemical inventory system. So one of the key things, at least with lean, is you want to standardize these things.

Aufra Araujo: Yeah, I also would like to add that maybe for folks on the call, just thinking about it, as Jill shared, these three topics, maybe think in your lab, what is your experience with, for instance, any of these three topics, and if you can share where you are in relation to these three topics. Maybe that will help. Have you ever had any nonconformance in any of these three areas, for instance?

Don’t be shy. There is no right or wrong answer, and no judgment. Is it possible to have a 100% and no conformance ever. So we are amongst friends. We all understand. And I’m sure you’ve been there as well.

Jill Power: So somebody did put in chat, thanks, Nick, to form a team consisting of leadership and lab staff to find a chemical inventory system to test and deploy by the end of May. That’s a great start. Thank you. Anyone else? You know you have ideas.

Aufra Araujo: Someone else entered in the chat. Oh, it’s Michael Stevenson. We are now using a Qualtrics workflow to document our drills, exercise, incidents, including safety, outreach activities, and nonconforming quality events as well.

That’s great, another, Macey Henning– sorry if I’m mispronouncing your name– wrote in the chat, autoclave sterilization. Consider the manufacturer’s requirements along with the best practices of your lab to write validation procedures going forward. Reach out to other labs for guidance if needed.

Jill Power: Thank you, Macey, for that. And at the time, what they did find for the validation procedure was that they could not find a procedure. And so you assume that the manufacturer who installed them did that. And we just couldn’t find it for any of our laboratories.

Oh, thank you, Angelica, for that. Yeah, she wrote, consider your state requirements and regulations, since they can differ. Contact them before establishing your procedures. So thank you for that. It’s helpful.

Oh, and Robin, you’re using a standardized chemical inventory system, WASP, I’ve heard of that, to go live by mid-November. Good. We use an academic fellow person to help assist in this project. Well, there you go, Michael. You can have them set up an inventory system if you need it.

Aufra Araujo: Yeah.

Jill Power: OK, so let’s go on to the next– I’ll show you what we did end up with for objectives. So if we go to the next slide. Thank you, again, for all of that. So this is the three that we ended up with.

So for the first one on the reporting system, the quality manager will create an electronic reporting system for the drills, exercises, incidents, nonconforming events by February 28, ’23. And the measurable would be to document 100% of all of these drills in the calendar year. So we already heard from Michael that that’s happening. So he set that up already. Kudos to you, Michael.

On the second one, the safety committee will create a standardized public health lab, biological and chemical inventory system by May. And the measurable would be 100% of individual laboratories will begin a biological chemical inventory by the end of this year, by 12/31/23.

And the last one about the autoclave sterilization validation procedure was to be established by August 31. And the safety committee will perform autoclave sterilization validations on 100% of the laboratory’s autoclaves by December 31. And just a reminder that an autoclave validation is different from your verification, which is typically done using your bioindicators on a regular basis.

So by outlining these objectives, they are accomplished by using the PDCA cycle. New Hampshire made a plan. They deployed the actions outlined and are measuring them or have measured them, and will evaluate them by the end of the stated date. And once successful, these become routine activities for the laboratory. And all changes will be communicated to the staff. So I hope that was helpful for people. Next slide, please.

Challenges around integration. This is another open discussion. From everything that we’ve talked about, putting it into perspective and how you think you can integrate a quality system into your biosafety program. So to get started, do you think you could easily merge them, if they aren’t already? And if they already are, are they successful?

So if you could please enter into chat or come off of mute to give us your examples, that would be helpful. What are some of the challenges you see in coordinating the two areas, safety and quality, if any?

Time and resources. That’s true. And Michael’s challenge is getting the staff to document these quality events in our Qualtrics workflow. I know how that feels. And it does take time to go after people and completely get them involved and remind them that these things have to be done for your quality reasons and safety reasons. Whenever you follow any of these regulatory standards, and it’s necessary they need to understand that. All right, thank you, folks, for those. Next slide, please.

So here are a few of the challenges that we felt about integration of the two. And there’s some of the things I’ve come up with. Safety and quality are not foremost in everyone’s minds. Some consider it fluff or extra work and not the important stuff. They think that their testing is much more important.

New staff are not confident in standard laboratory practices, so they may not understand what safety and quality and how that’s built into their new lab practice. And as someone said, there’s not enough time available to devote to staff training. Adequate representation from staff on the safety committee, primarily, managers.

And the lack of understanding of what helps build a culture of safety and quality, sometimes some people are just, let’s just check the box off. We’ll say we’ve done it. Yeah, we know. So we do hear you. We do understand that there’s always challenges no matter what. Next slide, please.

So a few suggested tips and tricks. On this slide, I’ve put down some tips and tricks, no treats, to help you achieve quality in your biosafety program. Control your safety documentation. So again, by standardizing your documents, you will convey the same messages time and again to your staff.

Make safety a quality indicator and track it. Use your log of incidents or near misses to track for six months or a month or a year, whatever your time frame is. And then look to see if there were any failures in that system.

Involve your safety officer in quality management meetings. Safety objectives benefit from quality improvement activities and oversight. And hire personnel that focus on customer service internally and externally. Make them understand that it’s important for them to be involved both within the lab and your customers outside of the lab, that they focus on safety and quality improvement.

Teach and train and mentor your staff at all levels, because as things become new– so ISO 35001 is new for folks– management may not understand it. They may not realize the importance of it. But those of you working in BSL-3’s, -4’s, you understand why you need to have this document. And catch people when they’re doing things right and show concern for their workplace. So celebrate those successes.

Anything else that anyone would like to list, I’d love to hear it. And also, if, as we close out this session, is there one thing that you heard or saw from today that you’d want more information on or discussion about or something that you would bring back to your laboratory? So if you could put that in chat, that would be awesome.

For those of you who have a quality manager within your safety, have you heard of some of these quality tools? Do you know that they are following these tools and using them routinely?

Oh, thanks, Kathy. The RACI chart. Yeah, it’s very simple to use. You can make it look how you want to. I think you’ll get these slides later, so you certainly can develop your own with how it looks

Well, thanks, Macey. Appreciate the reminder to review changes again. Often groups see problems and make changes, but following up on the changes that were effective is important. So that’s true. That’s true.

Well, thank you, everyone. If there’s anymore, feel free to put it in there as we finalize this session. Last slide, please.

That’s just thanking you. And if you have any questions, that’s my backstep right now. Because it rained last night, so these poor little straw people are all wet. So thank you and Happy Halloween to everybody.

Aufra Araujo: Thank you, Jill, for your excellent and informative presentation. Let’s give just a few minutes, see if anybody has any questions for Jill on what was discussed and presented. I see thank-yous in chat, but no questions yet.

All right. So it seems like no questions. People got a lot to think about. Oh, one question.

Jill Power: Michael, so I did contact– I know we have PJLA. And I did contact them to see if they would be interested. They’re waiting. They sounded interested, to the point of saying, of course, it will cost the lab more money to add it on to your already ISO accreditation. But they’re looking into it to see if that is something doable for them. So we keep plugging away, eventually somebody will do something.

Aufra Araujo: Right. Any other questions? OK, one more. Jill?

Jill Power: Robin, they did do a webinar a while ago. But it wasn’t really– it was more about, what is ISO 35001. But we can certainly let them know that there’s interest out there.

Aufra Araujo: All right, so with that, thank you, Jill, for your excellent and informative presentation and discussion. Now I invite my colleague, Commander Sabrina DeBose, who is the Safety Team Lead in the CDC Division of Laboratory Systems, to provide a summary of the discussion from today’s session. Sabrina, over to you.

Sabrina DeBose: Yes, thank you, Aufra. And thank you, Jill, for that presentation. So we also want to thank all of the participants for your robust discussion today. I know Jill had a couple of poll questions, and you all were very active in responding to the poll. And Jill did provide– we went over that information. So I will provide a summary of some of the comments that were in the chat today. During the discussion regarding SMART goals, many of you shared your different experiences.

One of the examples that was shared was that their laboratory was using a standardized chemical inventory system, also known as WASP, to go live, and that they planned on bringing it laboratory-wide by mid-November. And they were planning on using an academic fellow person to help and assist with the project. So that was an example of one of the SMART goals.

Also, during the discussion, what was most challenging in coordinating safety and quality, two examples were noted were identified as a lack of time and resources, as well as getting staff to document the quality activities. Another comment that was placed in the chat, and I believe Jill did cover this in the very part of the discussion, about the importance of bringing in some additional help, such as, I think, Michael Stevenson identified bringing in a new fellow.

So at this time, I want to say thank you all for the discussion. And Jill, I will turn it over to you in case there’s anything else you would like to add to those details.

Jill Power: I think you covered it well. I just hope that folks are able to take this back and talk to your management to bring in safety and quality together, because they can go hand in hand. When I was Chair of the LSS, Lab Systems and Standards Committee at APHL, this was a topic we were going to bring in before the Biosafety Committee came in. So it’s definitely on people’s minds. So please consider it in your laboratory, combining the two, or working hand in hand with each other.

And we do have resources at aphl.org. So you can always go there and just search for safety or biosafety or quality. There’s plenty of presentations I’ve done in the past that would be on there as well. So thank you, everybody.

Aufra Araujo: Thank you, Jill, for your presentation and for the summary, Sabrina. I would also like to thank all of our participants for taking part in the discussion today. We look forward to your participation in future sessions as we dive into specific laboratory biosafety topics. Let me just share back these slides real quick.

Yes. All right, now I would like to talk about the post-session survey, which we’ll be doing a bit differently this month. In the chat is the link to the survey for this ECHO session. It should take you directly to the Qualtrics survey.

So we are ending a little bit earlier. You will have time to complete the survey right now. You just find the link in chat and go to the survey link. This survey should take no more than two minutes to complete, and your participation is voluntary.

Previous survey feedback has greatly contributed to these sessions’ improvements throughout this year. We’ve used sessions– sorry, we’ve used suggestions, such as shortening intros at the beginning of each session, incorporating breakout rooms, adding other forms of interactive elements like polling questions, and providing resources in the chat to enhance accessibility. We appreciate your time in completing the survey. If you have any questions about the survey or the ECHO Biosafety sessions, please reach out to us at dlsbiosafety@cdc.gov.

All right, we are excited to have our next session on Tuesday, November 28, the week after Thanksgiving, at noon Eastern Time. The topic will be Laboratory Professional Vaccine Compliance and Effect on Safety, presented by Dr. Michael Pentella, who is the Director of the Iowa State Hygienic Laboratory at the University of Iowa and Clinical Professor at the University of Iowa.

Please visit the DLS ECHO Biosafety website to view information on the upcoming session and access resources from previous sessions as well. Now, we will adjourn. Thank you for attending. And I hope you are intentional about having a fantastic day. And Happy Halloween, everyone. Bye.

Additional Resources and Related Publications 

  1. European Committee for Standardization. (2011, September). CEN Workshop Agreement: Laboratory biorisk management.
  2. European Committee for Standardization. (2012, January). CEN Workshop Agreement: Laboratory biorisk management – Guidelines for the implementation of CWA 15793:2008.
  1. Centers for Disease Control and Prevention. (2023). Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition.
  2. International Federation of Biosafety Associations. (2019). Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document.
  3. International Federation of Biosafety Associations. (2021). Professional Certification in Biorisk Management: Examination Content, Sample Questions & References.
  4. International Organization for Standardization. (2019, November). ISO 35001:2019.
  5. World Health Organization. (2006). Biorisk management: Laboratory biosecurity guidance.
  6. World Health Organization. (2021). Biorisk management: Laboratory biosecurity guidance.