136a. RIPL - Biosafety & Biosecurity

• Lab containment levels 1-4
• Safety cabinets 1-3
• ACDP approved list of biological agents 2-4
• Counterterrorism act  schedule 5 pathogens
• Cat A and Cat B transport 
• SAPO?!

Confused? We're not surprised, but things will all become clear.... Once you listen to this masterclass from Dr Claire Gordon on all things biosafety and biosecurity from a UK lab perspective. 

Transcript

Callum 0:18

A special treat for the the very happy fans. We've got a little appendix here all about the biosafety and biosecurity and all the different things to think about with that, which I have to say would be very useful if you're sitting your part two FRC path or just generally working as a microbiologist and have to deal with one of these samples.

claire ripl 2 0:40

Or struggling to get to sleep.

Callum 0:42

So have a listen.

0:43

Hi everyone. Welcome to the Idiots Podcast. That's infectious disease insight of two specialists. I'm Ja. That's Callum, and we're going to tell you everything you need to know about infectious disease. Soon may the editing, editing come to discontinue the Tazo sun. One day when the CRP done will take our leave and go.

claire ripl 2 1:02

So a CDP the Advisory Council on Dangerous Pathogens.

Callum 1:06

And yeah, the A CDP document that they have is really useful'cause it tells you like, basically pretty much every pathogen you can think of and what containment level it is. And that, confuses me a because there is a CDP categories for the pathogen. So those are 1, 2, 3, 4, and one is like non-human pathogens, but then is the the level of your lab which goes 1, 2, 3, 4, but isn't the same. And then there's safety cabinets which also go up to 3, 1, 2, 3. But for some reason they're all numbered. But the numbers, because it's a category level four pathogen, it doesn't necessarily need a category level four lab.

claire ripl 2 1:50

You've opened a can of worms now, so I'm gonna go down there. So you have all of those, and then you also have some other conditions that that determine how you manage the pathogens. Which are sapo and Schedule V. So Schedule V refers to potential bio threat agents that have to be handled in a certain way, and Sapo is the specified animal pathogen order, which means that particular pathogens that might. Cause disease in animals need to be handled in a particular way as well that might be different to how you handle them according to their hazard group. So just to throw that into the mix. And then you've also got the HSO classification again. So Let's do this. The Hazard Group is, i'm a nerd. I'm a lav nerd.

Callum 2:38

this is such a hard bit of the I didn't understand this for so long and nobody ever really I think actually that's not true. One of my supervisor did sit down and explain the A CTB stuff quite early on and that was really helpful. But if you haven't had that explained here, it comes because it's, this would be also an excellent exam question.

claire ripl 2 2:56

Yeah.

Callum 2:56

I think, yeah.

claire ripl 2 2:58

So yeah, so your hazard group. Oh. The other bit of? that actually is the differentiation between biosafety and biosecurity. So the SPO Schedule five is actually more about your biosecurity and your hazard group And containment level. More about biosafety. So biosafety is about the risk to your lab staff, essentially, and the risk of accidental. Transmission or accidental release of the pathogen. And then your biosecurity is looking at deliberate release and preventing unauthorized access to pathogens or unauthorized egress of those pathogens if somebody wants to nick them from the laboratory. so those are the two bits that all of these different categorizations are trying to. Address. There's also obviously the transport group as well, so we have category a and category B for transport, and that again is related to the bio safety and the biosecurity. I know, right? And I don't even I can't think of how this would fit into Venn diagram. So your hazard. group is really about the risk of that organism to your lab personnel. So stuff that is essentially inert. So you're an activated e coli that we messed around with at university that doesn't cause disease in humans, that you can probably lick a plate that has group one. You don't really particularly need any. Particular measures for that other than, don't lick the plates. And then the hazard group two ones are the ones that may cause disease in humans but not severe disease. There's a treatment there's preventative measures, et cetera. So that's most of the standard pathogens. The hazard group three are the ones that do pose a more significant risk to laboratory staff that need to be handled at a higher level. so those are your TBS and your salmonella t feeds and then you've got your category four. The ones that cause severe disease in humans where there's no prophylaxis and there's no treatment. That really do have to be handled very carefully by laboratory staff. So that applies to the. Organisms. And then the containment levels are just a sort of a grading system for the levels of laboratory. So containment level one is your basic, usually a teaching laboratory where, things need to be kept clean, there needs to be some sinks. There needs to be, basic waste disposal. Containment level two, there needs to be access control to the laboratory. It needs certain, standard of flooring, a certain standard of windows, certain standard of, doors, et cetera. Containment level three is your higher level where there needs to be restricted access. You have to have two doors. You have to have, Observation into the laboratory so that if there's a, an accident laboratory, people can observe and see. That particular staff member isn't at risk. And then you've got your containment level four, which they're a handful of laboratories in the UK That operate at containment level four. And they handle the very high level pathogens now. In an ideal world, you would just say has a group one has to be handled at containment level one, but there is a bit of flexibility. Most of this is contained in A WHO biosafety. Guidance. so there's some flexibility in there about what you're actually doing with the organism that increases or decreases the risk. So if you've inactivated an organism, you can usually bring it down a level'cause it's no longer effective. If you are culturing an organism, if you're culturing a hazard group four organism, that's a huge risk to your staff because there's a high concentration or a high. Bioburden of that organism. And so it's a much, much greater risk. If it's a sample that contains a very small amount of that same organism, then potentially that can be handled at a lower containment level. So, that's what we do at Ripple. We actually don't do our primary testing for the, high level pathogens in. Containment level four. We do them at containment level three because the pretest probability of that organism of that organism being in a sample is actually statistically relatively low. And then if all you are doing is needle free extraction, so there's no sharps material in a C3 laboratories, so you are reducing the risk of sharp's injury, we handle them in a class three cabinet. So that's the one with the gloves. That's. Completely separating you from the organism. and we've done all the risk assessments and determined that is a safe way of handling a sample that might contain has a group four pathogen. Once we know a sample has that organism in it, and we're going to manipulate it, so do cultures or do any other sort of research on it, then that is done. In containment level four. So it doesn't look a bit like,, So if you watch contagion or the hot zone about the Ebola labs and things in the us it, it doesn't look a bit like that if you, if our team come in the middle of the night And, do, you know, VHF testing, they go into containment level three. They handle it in the cabinets, they put the PCR on, and then they go to McDonald's while the PCR is, chugging through. So it's it, they try and take the drama out of it, to be honest. Your safety cabinets are about whether they're protecting the sample or whether they're protecting you. And I, always get this wrong, but a class one safety cabinet, I think is protecting you. And the class two is actually really there to protect the sample from contamination. And the class three is to protect you completely from interacting with the sample. And then, yeah, the SPO is about specific measures to do with the the escape of those. Particular organisms that might be a threat to animals. So they have to be stored in a certain way. You have to have a SPO license in order to store those. So that if you are. working with, the example is foot and mouth disease. If you're working with that, people need to know about it So they can trace it back to you, should it escape and course an outbreak. And then the Schedule five is actually more about your security measures and whether people are able to access your lab. Or whether there's potential for unauthorized access to your lab. And Schedule five responsibility actually sits with the police. so if you're handling particular pathogens, you need to be informing your local sort of schedule five department in the in police force. and then they are actually the ones that come and do the inspections. So it's interesting, but that's much more about biosecurity and then from.

Callum 9:46

What's the schedule five of? Schedule five of.

claire ripl 2 9:49

I didn't think I need to know about this stuff either. And then you get to Ripple and everyone's oh, is that under schedule five? And I'm like, oh, what It's schedule five of the Anti-Terrorism Crime and Security Act, 2001. Things I didn't know, I needed to know in microbiology. But that's the thing. But that does actually limit to a certain extent what. Clinical laboratories can do. So that's why Ripple exists for certain organisms.

Callum 10:16

Just to round this out, spoken through so much there this is almost an episode on biosafety and

claire ripl 2 10:22

Yeah. you can cut all that and I'll come back and do another one.

Callum 10:24

Maybe we can just put this in as another

claire ripl 2 10:26

Show it in Yeah, you press my button like, look what happened.

Callum 10:29

So transportation category A versus category B, UN 3 3 7. 3 2 8 1

claire ripl 2 10:37

Oh, very good.

Callum 10:38

which this is part two, knowledge fresh in my mind for some reason. So UN 3, 3 7. Three is category B. And

claire ripl 2 10:46

Yes, although that kind of refers to the packaging and the labeling is the un bit of it. So that says, this is triple packaging and this is the label that you have to put on.

Callum 10:57

Oh, I see.

claire ripl 2 10:59

And it's actually the same, the packaging's the same for the two. But they like it to be have a different, sticker on it. But category b most samples can come to ripple. Even the suspected VHF samples would almost always ask for them to come category B, because they're only suspected and the courier. Transportation is more about biosecurity, so you've packaged it properly. It's Now bios safe. It's not gonna be escaping from that if you've put lids on the tubes properly and sealed it all up properly. So that is now a bios safe package, but. Courier category is actually about biosecurity. So there is obviously a risk, although hopefully incredibly small, that somebody's going to intercept that courier and run off with your Ebola sample. We consider that risk to be very small, given the pretest probability of your sample, actually having Ebola in it and a bad actor knowing about it and being able to find the coer and being able to stop the, coer, identify your package. We lose the packages sometimes, so if they find it good on them. So yeah so chance of all of that happening. Minuscule really. There's a slightly more and what are they gonna do with it if it's just a blood sample? They still need the lab capability to be able to propagate the organism.

Callum 12:15

more familiar of James

claire ripl 2 12:16

Exactly. Not gonna happen. It's a bit stricter if you've got pure culture of the organism. So we've run into this couple of times, this with Francisella pure cultures for example, because that's now on a plate or a slope And it's definitely there. Somebody could if they did happen to intercept it, they can do something with that. So pure cultures of certain organisms, particularly the viruses, once you know it's there and you've got a high bioburden of it, those have to come Category A. And also, once you've identified a patient and they're in a high level unit, there's a chance that somebody will know that patient now has a particular infection. Of a, an organism of interest. So if they really wanted to and again, like they'd have to be desperate to get their hands on a bit of a bolus, just sort tracking down a patient and finding a courier and then, waylaying that and Pulling the sample out. It does seem like a very small risk, but that's why those ones, if it's a confirmed case and or it's culture material, they have to come category a and the difference actually in the couriers is that they're tracked properly with category a and they're not allowed to leave them unattended. so, they can be very expensive if it's coming all the way, from. The north of the country down to Ripple. They will sometimes need two drivers, for example, because they need their rest stops and they can't leave the, fan with a sample in it unattended. But almost always for the suspected, vHF testing it's fine to send category B and we will almost always be advising that things can come category B to just.

Callum 13:49

has been so comprehensive and explained in a way that I've not had explained before. I almost think that deserves to be an appendix to this episode.

claire ripl 2 13:57

Stick it on. Nerd appendix.

Jame 13:59

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14:26

Now that the episode's done, we hope you learn and had lots of fun. So go forth and treat people with some of what you now know.