Pulse: Recent Publications and Our Lab Inspection Debrief

Hey, buddy. How you doing? I'm doing good, Dr. Ziner. How are you? I'm doing good. It's been a little bit, and I'm sorry that it's been a little while since we've last recorded, but it is great to see you. Same here and happy Labor Day? Yeah, exactly. Well, as you point out, we're really good at always being a little bit late, and so we didn't have an opportunity to wish anybody happy Labor Day. And you pointed out this weekend, when we had a wonderful meal with you and your wife and my wife, that my birthday was coming up, and that was yesterday. So, yeah, yeah, yeah, exactly. So, yeah, thanks, buddy. Again, we're really doing a great job of being late to the party. I remembered it. I remembered it. You remembered it, yeah. And then I forgot it because I had some work-related issues. Oh, yeah. Well, it's understandable. But, you know, my wife is fantastic. My kids are fantastic. And she has decided that I'm going to get, I guess, like, I'm not entirely sure, more than one gift, obviously, but it's going to be, like, some gifts throughout the week, I guess, because I got, yesterday, I got a PS5. I mean, I know, right? Like, I need literally no other presents at all. And I got a PS5, and I got Hogwarts Legacy, which I've been wanting to play forever. So, yeah, I mean, any more presents is too many presents at this point. So, I know, I'm pretty excited. You have your PlayStation. I have my new HD television in the office. I mean, exactly. What else do we want? I'm not saying anything. I'm not saying anything. I'm just stating out the facts there, okay? Yeah, exactly. Fact one, fact two, I mean, yeah. We just need some Dr. Pepper Zero, and that's it. And what's going on right now? Well, yeah, for most of our listeners, they probably saw that you and I published a piece in The Pathologist, which we were really excited about. It was based on a previous episode of the podcast. We called it The Vanishing Middle. They changed it to The Vanishing Middle in diagnostics. But really, the idea was that there's a vanishing middle, and it's the sort of laboratory-sized middle, meaning that there's the centralization, regional centralization, like the big labs, and then there's the small labs, like point-of-care testing and clinical labs, and then there's the hospital, the sort of traditional hospital space. And those aren't necessarily being squeezed a ton, exactly, because the number of CLIO licenses have stayed about the same at academic centers, but the number of, you know, clinic labs has exploded. It's, like, tripled in the last 10 years. And then, obviously, centralization is happening as well, and so a lot of the volume is going to those places. So there is a squeeze there, but our point was that not only is there that squeeze, but there's also sort of a vertical squeeze, and that vertical squeeze is the intellectual one, which is what's the difference between a result and then a conclusion about the result? So you get a number, and then it's sort of like, well, now, therefore, blank, like the patient has disease A, B, or C, what we should do about it, what's the therapy, et cetera. And traditionally, that has always been sort of a quasi-space between the laboratory and the clinical faculty, or the clinical team. And it's our belief that we can extend ourselves a little bit further into that space, and this is kind of consistent with the DMT concept, the Lab 2.0 concept, so it's all in that same family. So I thought it was a pretty well-received piece, and I'm pretty excited to have it gotten it out there. Good. Good. No, we worked at it for a good time. It was nice working with you on that. And then we recently were at the receiving end of something that was like, usually we are going to inspect the labs, and this time we were inspected at one of the locations. And I think that's also very, shall I say, timely in terms of, like, we have always given this talk in a series where we, from the inspectors' perspective, I think this would be a nice topic that we could discuss today on the inspectees' perspective, right, what happened and what we were expecting and how did it go. And I think it was a very fair and decent experience for all of us there. Yeah, I mean, the first thought I think that you and I had was the team, so first off, we were part of a four-hospital health system, and really we have kind of three tiers of institutional size. There's the main hospital in Galveston, which is by far the biggest. It represents roughly half of the total beds of the system. And then there are two hospitals that are kind of in the middle, and then there's a much smaller hospital. And we were inspected at the much smaller hospital. And the team that came was pretty legit. I was really impressed with the credentials of the institution, or the members of the team that came. Yeah, and it was actually a fairly sizable team also for the lab that we were expected for. So that was something we were also... I wouldn't use it with intimidating, but it was mostly like, you know, we were surprised with the size of the inspection team compared to what they were inspecting. That was something a little bit above all, but we did good. We did really good. Yeah, yeah. We've had, at that site, the last three inspections have been all over the map. Two inspections ago, we just had one inspector who was a professional, and she came for one day, and then was gone. And then this last time, we had two inspectors. One was a trainee, and they were here... I actually think they were here for a day and a half, actually, now that I'm thinking about it. And then this time we had seven, right? Is that what we had? We had seven? I think it was seven inspectors for a day. And so, I mean, it was a bit... Yeah, and maybe not quite intimidating, but close. It was in that space. I certainly was surprised and thought, oh, man, this is something. Yep, yep. So, yeah, based on that, I think you and I were speaking about it, that wouldn't it be nice if we had an episode where we were talking about our experiences and what was our takeaway as an inspector this time. And I think that's something that would be really eye-catching. Yeah. It would be something that's to what we have been telling our listeners about what happens when we go as an inspector. Right. Yeah, so one of the first things... So you and I looked back at some of our old episodes to kind of see what we had been preaching. And oftentimes, I think people sort of panic leading into an inspection. And so the question I had for you was, how do you feel like we were going into the inspection? Did we spend an inordinate amount of our time telling everyone not to panic and don't worry about it? Were we anxious leading up to it, or were you and I afraid? Well, to start with, we weren't afraid. We weren't afraid. I mean, like, to give those to a team, we have some of the amazing team members that... I mean, I'm telling you, not because we did it, but that are really good at what they do. That's one thing. And the second thing we... Just to mention, this was the first inspection since the cap started that 14-day period thingy. So we knew exactly 14 days beforehand that what's going to come. And frankly, as we have discussed there, that we took it to our advantage, right? Not that if it wasn't that, the results might have been different. No, it's not like that. It's just that we utilize those 14 days to our advantage. Just like we have told our listeners and our rest of the people as well that this 14-day grace is your chance to shine and to do better than you could have expected. Of course, panic was there. It didn't turn out to be, as you say, like your regular weekday. But also at the same point, it wasn't a very drastic thing that was happening to us. Right. Yeah, I think you're right. I think... We've talked about this before. I'm afraid of what's going to happen with the 14 days. I feel like what's very likely to occur is that we're likely to see people prepare and then start to degrade that preparation until 14 days and then they're going to freak out. So I think that we did not do that. I think that we were preparing like normal, but then we kind of kicked it into gear at 14 days. I agree. Yeah. So the second thing is, how do you feel like we acted vis-a-vis? Was this sort of like any regular Tuesday or Wednesday or was this something that was completely different than a normal day and we really went after it? I think it's just, again, it's the same on the same grounds, but it's different that did we panic? We didn't panic. But did we behave as a Tuesday? To that, I would say mostly yes. And that too has to do with the team members getting ready, number one. And also the fact that we had been primed for this day for previous 14 days. Having said that, I mean, of course, we did have more traffic than usual in the lab that we expect more people to look around than we would expect on a normal day. Like you were looking at people that were coming in lab coats and wearing ties and all that and you were like turning your head to the next. I don't know who's this person. Right. Right. Right. Why is he staring behind my neck? Things like that. But I think for the most part of the day, we were doing good. And I think we also spoke about why was that. And I think you mentioned also that it's also the reason that it happens is when the lab and its core is really working fine. Instead of getting panic in a panic mode, you actually try to boast about it that, yeah, let me show you how good I do that. Yeah. Yeah. Yeah. Right. So so that was one of the cases. And I think it was we did quite well. Yeah. Yeah. I mean, I think that the way that we tend to do things is we're anxious to show off, as you pointed out, and not like obviously in a braggy way, but in a we take this very seriously, being ready for an inspection is something that we really pride ourselves in. And as such, we had multiple medical directors there. We had technical supervisors and managers from all of the different sites there and a high number of administrators there. And so, I mean, it was a it was a pretty legit effort from our institution to help the inspectors, of course, because we either have a deficiency or we don't. But also to show them how serious we take the inspection. Yeah. Also to show them like the ownership of it, like we are we take full accountability of the work we do and we are invested into it. And I think one of the one of the things that we have talked about, like when we went to inspection, we were we were we were happy to see every single person that is involved in one way or the other being present over there. When they went before the pre inspection talk or something. And the same thing as we always say, like, you know, each what you practice, we did it right. We were there. And if you remember, we were actually acknowledged by the team that this is something that that's the first thing that they notice, like every medical director, related medical director, every personnel, every testing personnel was there for them. Yeah. Yeah. Yeah. I've never seen it like that, actually. I think we do it more than the majority of places that I've I've been to. And that's not to say that it's not true everywhere. But we did go to one place. It was pretty similar. And so it's, yeah, it's a sort of all hands on deck. I am. I'm curious to know. And I was actually unable to be at the opening meeting. So how did you feel like the opening meeting? Did it set the tone for the inspection? Do you know? I mean, it's kind of hard for us to know. We know what we present to the world. It's kind of hard for us to know what how they perceived it. Well, see, the thing is, like, that's my understanding that when the pre inspection meeting happens, right, the whole point of this, that meeting is to set, as you said, set the tone. By the tone, I mean, just in fact, if present trees there, there's introduction to every person. And then the team that's like telling us, like, hey, we are, we are the team that will be expecting you. This is the background. These are the credentials to which you are surprised. And actually, it was not intimidating, but it was very surprising. Oh, we have got so many people and they are really good at what they are doing. But at the same time, then we opened our cards and let them know that there is Dr. Janner, here's Dr. Aakash, here's the current medical director present over here. This is the technical supervisor, there's the manager over there. These are our staff over there. And this is this, everything is doing. And then we presented like, okay, what you have, we will try to accommodate you. And then we started building, like, you know, groups of teams, right? And attaching, having an attaché with every other person that they wanted to, and then guiding them through the entire process. So I think that actually sets the tone in a way to say that we are not intimidated, neither we are unprepared. It's on the contrary, we welcome you to come and help us identify our good sections of our lab. And also identify together with us, where are the areas that we can improve. And that just tells them of the inspecting team, that the other team was like, okay, they are full blown head and neck down into improving their lab. And this is what they want to do. Yeah, yeah, I agree. I am curious, you know, we've leaned pretty heavily on three general questions that we think help the lab and sort of prepare for an inspection. What do you do when QC fails? How do you know an instrument isn't working? And then what do you do with an unexpected result? And basically, those three questions kind of encapsulate a large percentage of what we're actually inspecting during an inspection, whether it's, you know, proficiency, validation, etc, etc. Any of the things that you're typically going to be looking for are more or less encapsulated in those three questions. I noticed that all three of those questions were asked actually frequently. Now, they weren't necessarily posed in exactly that way. But almost every one of our citations, which we had, I don't know, very few single digits, I can't remember. Yeah, it wasn't very many. We're in one of those three questions. And so I thought it was actually pretty validating that you can really kind of encapsulate an entire system to just those three. No, and I agree. I mean, the thing is, these three questions basically encapsulate the entire working profile of your lab, right? And I think we have had this position where there is a thing called something is right on the paper versus something that is being correctly real life. Real time. And I think this thing, these three questions really directly ask us, like, if we are doing something real, then what happens when you've done this thing? Can you show me? How do you do that? What do you do when that happens? And this thing also kind of reflects the idea that I might know thing just because I passed by through a wall that has written everything. And I just, you know, know that is there versus whether I actively, if you wake me up from the middle of that, I didn't ask me what I can tell you. And this is this practice tells you that this lab has been doing this thing frequently enough to know that how to, you know, troubleshoot. And at the end of the day, you know, it's you, it's a lab system. Everything has its limitations. You are going to get citations. But as long as you learn from them and then you can acknowledge them, the reason that this was cited, which was our case also right, then you have probably nailed it. Yeah, it's it's funny you say you're going to get citations. I sort of wonder. Sometimes I almost want us to get some because I want us to find areas where we can get better. And then sometimes I'm like, I don't want to get a citation. I want to be perfect. Yeah, you know, it's like it. It's sort of a one day of the week. I feel one way. Another day, I feel another way. I was somewhat disappointed that we got any, you know, but it wasn't. These weren't a lot. I was very proud of the team, of course. But yeah, no, I mean, I think I think we kind of nailed it. I will say, like, as far as things go, our previous episodes actually held up fairly well. Those three questions in particular, I found to be incredibly useful. And so again, those are what do you do when QC fails? It's a fairly straightforward question. A lot of people get it. How do you know this instrument is working correctly? Again, very straightforward question. There's nothing hiding there. And yet, very rarely asked. And then what do you do in an unexpected or with an unexpected result? It's remarkable the number of times we've been an inspection. And that last one, people just don't know what to do with it. There is no process. There is no improvement plan. There's nothing. And so it's it's pretty interesting. And I think if you can answer those three questions for every area of your lab, and everyone can answer those three questions, your lab is going to have very few citations. It's almost it's almost a guarantee. Yeah. And as we have said that earlier as well, it's it all boils down to the values of the lab, right? Values, not the numbers, but actually a day to day business, right? It's just a reflection of day to day business, right? If Yeah, yeah, yeah, exactly. That's just the entire scenario, pre pre inspection. You know, meeting was just across if you just if you can relate it to that, that's like somebody comes to my lab in the morning, says hello to everybody and tells them I'm on this particular inspection team. These three questions, we do it every day, every take every then has to be done, right? So do you do that post inspection at the end of the day, we sit down together and see, like, did the did the machine work fine today? Did was a lab working the way that we want? If not, then yeah, these are the few things that we need to work on. And then tomorrow, next day, we come back again and do it. It's the same thing. So it's just now it is somebody who's going to do it again and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again. and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and again, and