Successful Compliance Investigations from Start to Finish

Investigations are a natural part of any compliance professional’s career – but that doesn’t make them any less intimidating.

We invited Eric Allen, a highly regarded compliance professional with experience spanning academia, hospital institutions, and more, to join us for an episode of Compliance Conversations! Eric's expertise includes in-depth investigations, policy development, education, and regulatory interpretations, and he offers specialized insight into compliance investigations.

In our latest episode, “Compliance Investigations 101,” Eric and CJ Wolf, MD, discuss the nuances of investigations, including:

• • How to set investigations up for success from the get-go
  • Navigating the emotional side of interviews and ongoing investigations
  • Why mannerisms and body language are crucial in the age of remote interviews

  Thanks to Eric for sharing your time with us – we hope you enjoy the episode!

Episode Transcript

CJ Wolf: Welcome everybody to another episode of Compliance Conversations. I am CJ Wolf with Healthicity and we're excited today to have our guest Eric Allen with us. Welcome, Eric!  

Eric Allen: Yes, thank you for having me, CJ. This is a true pleasure and honor to be here on your podcast today.  

CJ: Yeah, we are. We were talking before we started recording; Erick’s in the sweltering heat of Texas! 

Eric: Yes, I am.  

CJ: Yeah, but it's a good place. I've spent some time there, as many of you know, and wonderful institutions and things. We're going to talk today about investigations, which is a really important topic for compliance, right?  

And as normal, we like to give our guests just a moment or two to tell us a little bit about themselves. What brought you the compliance, what you're doing, what you've done, what you're doing, those types of things, anything you're comfortable sharing.  

Eric: Well, I've been doing compliance pretty much my whole life. It's almost the only thing I know, and it's also one of those things, as most of you guys know from working incompliance, it’s one of those things that's very difficult to explain to people outside of the profession. In my time in compliance, I've worked in academia, academic medical centers. I've done some consulting work. And I've also worked in different hospitals as well. So, my experiences go across general compliance, and institutional compliance, and at some points in my career, I've also veered off and done almost everything except HIPPA and NCAA compliance. So, the animals, the humans, you name it, I got all these acronyms in my head and federal agencies! 

CJ: I know it's like another language sometimes, isn't it? And I appreciate what you said about not knowing all the time how to explain it. Like, I'll just try to explain it to my kids and like, "What do you do again? I teach people about rules. Oh, that sounds really boring, Dad!" But a lot of people in healthcare get it, we know that it's a very regulated industry and we appreciate your years of experience and we know you've been involved, as most compliance folks are, in some sort of investigation, at some point, it might be small, might be medium, it might be big.  

So, we thought we would talk today about investigations a little bit. And would love to hear your thoughts on, you know, let's see, if you've identified you need to investigate something, usually one of the first things you're doing is you're starting with an interview of some sort. So, curious if you have any thoughts or strategies that somebody can deploy to successfully conduct an interview when you're doing an investigation.  

Eric: Well, it's one of those things that it's never the same. And for those of you who have done this, it's one of the biggest challenges because you will get a tidbit of information that you need to peel back somewhat, like an onion, and each time you have to use a slightly different approach, but you want to be consistent if you have a policy in the specific area in which you are going to be doing the investigation. So, in particular, if you're doing research misconduct, that is very prescribed because of the implications of what you're investigating essentially as someone's career is on the line. So, we must stay in line with that.  

And outside of that, you want to make sure that all your, you know, the exploratory questions, the who, the who, the what, the where, the how, and the when are all addressed, and as you peel back each layer, you also tend to increase the list of people you need to talk to. And I think that's the most important thing is learning how to be that active listener and being able to try to drill down for finding out the additional things you need to explore. Because when you get that initial tip, it's usually just that, the tip of the iceberg, and as we all know, the majority of the iceberg is much below the actual water surface itself.  

CJ: Yeah, that's such a great point and I appreciate you just saying that each interview is like different, right? And a lot of it has to do with personalities. Like you said, "What's the tip? What started the investigation?" And like you said, you rarely have all the information. That's why you're doing the investigation and what somebody brought up in the hotline or something, might not even be, at the end of the interview, you're like, "Oh! This is going in a totally different direction!"  

I know that's happened to be sometimes you follow that issue and then they are bringing up all these other issues and you have to keep it straight to say, "Okay, those are valid points there. They seem to be outside of this particular issue. Let's jot those down. Let's deal with those. You know, in another parallel path or something." That's really, really good advice.  

When you're getting ready to interview, do you kind of write out your questions ahead of time, depending on what the concern is? Or do you wing it or a combination of both?  

Eric: My personal approach, I like to call it the shotgun approach. You're going to have to do everything because you're going to have to ask questions specifically about the information in which you got the tip. And as you said previously, it can lead you down different paths. Sometimes you can identify the need to do multiple investigations off of that one tip.  

So, your questions have to figure out what this person knows and what that can unveil to answer all of the who, what, where, why, and how questions so that you can actually say, "You understand everything that happened. You understand that there's a clear path for rectifying it if there's a need for reporting. Or what the total ramifications are," because as the compliance person, you have to reiterate that up the chain and down the chain and sometimes outside of the organization.  

So, you in your mind have to think about all the different things that you have to do downstream and pull as much information as that interview as you can to achieve your goals of doing all of your follow-up work following the actual investigation.  

CJ: And in regards to kind of what you were just saying, sometimes you start in and you think you might have the subject matter expertise when you start, but then it goes into an area that maybe you don't have the subject matter expertise. You know how to do an interview, and you know how to do an investigation, but you might not be able to do everything that you want to do until you get more subject matter expertise and what you're looking at.  

How can you get that subject matter expertise while still trying to maintain confidentiality and kind of the private nature of an investigation?  

Eric: That is probably the biggest challenge with an investigation, especially if you're at an organization in which you have extremely high-level investigators that are at the top of their game or the top of their field so that the type of work you're on the map are going to be asking questions about is known by people in the industry.  

And it's usually a relatively small network of experts and in that statement in of itself, you want to try to vet these individuals, one for having knowledge. And two, try to do some sort of conflict-of-interest assessment, meaning; if that person is also potentially going to be an expert to help you understand and evaluate things, you don't want them to have a conflict with the individual. They're not on a grant. They're not collaborating in any initiatives, because that definitely would not work. 

But on the flip side of things, you also want to be careful that you're not vetting two different rival companies, so to speak, or individuals that are working on the same type of research. When you get into the IP realm or you get into devices, it gets a little tricky, so you kind of have to walk the tightrope of finding that individual that doesn't have any apparent issues and then trying to negotiate either, depending on your organization, some type of agreement that would not be like something so much or non-disclosure or some other confidentiality type arrangement.  

CJ: That's such a good point, cause you steered us a little bit into the direction of research because you're right. A lot of that, you know, there may be a non-disclosure agreement already and you're not allowed to disclose certain things, especially in the research realm and you know academic medicine, you're working with for-profit companies, they have their legal agreements, all these sorts of things. So, working through all of those nuances can be really, really like walking on eggshells sometimes.  

Have you used in the past, like doing investigations under, like attorney-client privilege? What would you say, how often has that been the path versus doing it under compliance? Or you're doing it under compliance, maybe halfway through it, you're like, "This better go under attorney-client privilege," or is that not an area that you've had to deal with very much?  

Eric: I've had to do it both ways, to be honest with you and I think it's kind of one of the things we talked about early, we don't know what you have until you start digging. So, I've been on cases in which is just strictly compliance in my lane. And then all of a sudden, I get thrown a curveball and I have to go contact the lawyers and say, "Hey, this popped up. We might have to do this component under privilege, while I do the parallel component for compliance."  

And it is one of those things that you just never know. You just have to have the contacts and make sure everyone is aware of their role within those processes. And that again, you're staying within your policy and sometimes you have to go outside of your organization for the particular council that can assist you in some cases. So, I haven't had to do that one personally, but I am aware of having to farm that out.  

CJ: Yeah, absolutely. And that kind of drills home a point we've talked about other times on the podcast of just having a good relationship with your own legal counsel. We've, in past episodes, talked about reporting structure and OIG and some other agencies. Have some grief about the compliance officer reporting directly to the in-house counsel. But even though if you're not reporting to them, you still need to work with them and kind of balance all of those different needs of the organization, so to speak.  

How long on average do your investigations take? I mean, maybe just give me a range. Like, can you get some investigations done in days and some take months or years? What have you experienced?  

Eric: I've had some that have taken days. I've had some that have taken months and I've had some that have gone on for years and it just depends, because sometimes you'll have a tip that comes in that has no merit and you can squash that in a couple of days, that's a slam dunk, is what I would like to call that one, they don't happen often.  

Then I've had cases where I've had Office of Research Integrity call me and tell me, "Well, we've got a complaint from a professor that says so and so student has plagiarized their work and these are the sections that we want you to look into, by the way, we reviewed your policy and we think you need to make some tweaks after you do this investigation."  

And in that case, it's more challenging because the timing is applied in the policy, so you're restricted within those timelines and you can request extension. So, that's where you get into the few months there.  

And when you start getting into years is when you have really serious investigations, where you have egregious actions on behalf of some of the staff and positions or whoever, and you're having to go through articles for the last fifteen, twenty years, look at all their grant work, collaborations, literally their whole portfolio for the last few years. That's when it becomes to be hugely, hugely time-consuming. And typically, that also means you need to get that expertise that can also come through it and help you tease out details as well. So, there are a lot of different caveats that you have to consider, so timing can be days to years.  

CJ: Yeah, that's kind of what I've experienced too. I appreciate that response. Let's take a brief break and then we'll be back with Eric Allen to talk some more about investigations.  

Welcome back, everyone from the break. Our guest again is Eric Allen. We're talking about compliance investigations and we've talked about some good things already and we're going to continue that conversation. We started talking about interviewing and sometimes investigations can get emotional, and especially interviews. Have you ever had to deal with emotional outbursts and how do you deal with that? How do you stay calm? How do you stay objective? Any thoughts on that?  

Eric: Yes, I've seen both sides of the emotional outburst I've seen in academia when you have the investigator that is extremely concerned about their career and they just go crazy on you. They're yelling. They're screaming. They're angry. Every word they can think of to insult you or the group is being used.  

CJ: Yes, I've been there!  

Eric: And you're trying to stay on track and not take it personal. And that is the biggest challenge is understanding that it's not personal. They're fighting for their career and that's where we have to kind of focus that on the flip side, I've had an individual that felt like, you know, she was targeted by the organization and scrutinized in a way that was unfair to her. And it was very challenging to have her crying in every session, talking about all that she's achieved for the organization, which were all facts. She had done a lot for the organization. But she had also violated several policies. And I think the emotion of recognizing that, she broke the rules. She was a high-ranking individual that could have known better! And I think the impact of that and the gravity of what she knew she had to accept, and what her colleagues would think of her was imminent, so it was up to my team to try to listen, calm her and say we're going to work through this, but not get to an emotional exchange that separates you away from your ability to be objective and to achieve the end goal.  

CJ: You know, it's hard because, like you just said these are, you know, if somebody's being investigated, it could be their career. It could be, you know, meaning some sort of discipline. And so, you try to say, "Oh, don't take it personally." It's like how can I do anything but take it personally? It's either my integrity or my work, which I take very personally, is being challenged in a way, and so it's one thing and I don't know what your thoughts on this, like one thing I've tried to do is just to make sure I don't use the word, "I" Like, I think or you know, I try to just like you said earlier, the reporter's questions, "Who? What? Where? When? Why?". And kind of stick to factual and as sanitized as possible, keeping opinion out of it. Does that ring true to you? Is that a good approach?  

Eric: It's definitely a good approach. The one thing I would add to that is you always want to acknowledge the person, even if you don't say I understand what you're going through, you got to at least acknowledge the fact that this is a situation that brings out a lot of emotion. Understanding what they're going through because the biggest issue when you have an emotional outburst is they're trying to get a response, and if you don't respond with anything, acknowledging what they've just said, it makes it worse, in my opinion, from what I've seen over time, it's just like; "I'm pulling my heart out to you. You don't understand!" 

CJ: Right!  

Eric: You got to acknowledge that and let them know I'm hearing you. And then try to move back along track but you cannot ignore their emotions and those emotional statements.  

CJ: Yeah, I that's so good. When you just said that I almost thought you're in a way a part therapist for a moment. Like you just said, "I'm hearing what you're saying," you know. And you said before, in that other scenario where the individual had given a lot to the organization, "Yeah, I totally see that you've done this and this and I'm sure that's appreciated and it can be difficult."  

One thing that I have tried to do is especially if I'm following a policy, when I sit down with the individual, I'll just outline the mechanics of the meeting; "I'm proposing today that we meet for our scheduled 45 minutes. If we need to go longer if you have more to say, we'll be happy to reschedule and do additional. I do have to leave after 45 minutes," so, I like to sometimes put bookends around it so that if it does get like super emotional, I know there's like a time period that I threw out there that will end at this time. I usually like to describe to them, "I'm following this policy. You have a right to do, yadda yadda yadda," because usually the policy will have some sort of right that they can either have somebody with them or they could appeal eventually, or you know whatever just kind of outlining so that there are no surprises in the mechanics of the interview. I usually say, "I'll just basically ask you for what you know and ask you these kinds of questions." And I think sometimes that puts people at ease as much as they can be, and they're being interviewed. Have you ever tried any of those tactics or have you seen other things work?  

Eric: Well, what you identify are really good strategies to kind of disarm the person in some ways by giving them structure. A lot of times people go into these interviews and they've never been in one, and they're just... anxiety!  

CJ: Right!  

Eric: And you know the main thing that you want to do is to bring the anxiety down by telling them just what you said, "This is what we have to work with. These are my goals and this meeting or this an investigation." And allowing them to have as much information as possible to empower them to be engaged in understanding what the process is and what their expectations are, and I think that has been that is extremely successful. 

And one of the other things that that I like that you brought up is trying to, I call it my bailout is what I like to have and, in some ways, you get thrown a curveball and at that moment you automatically know this needs to end now I need to go in another direction and in that, I try to keep in my back pocket some ideas or things that I can use if I get that curveball in the actual interview.  

CJ: Yeah, because you got to be prepared for that. And I think as interviewers and investigators, we get more and more comfortable, the more experience we've had. So sometimes for like a junior investigator before you let them go out and kind of do this thing on their own, we've required that that junior investigator observe a certain number of hours of interviews or something like that, just so that they kind of see by example or by modeling how we'd like the interviews to go, that sort of thing.  

One thing that I wanted to ask you too, sometimes the person you're interviewing, they have right maybe to legal representation. How does that change your whole process? Like I'm imagining, that's going to be a major shift or maybe not. What are your thoughts when the person you're interviewing either insists on legal representation or they already have them there?  

Eric: Well, before I say I want to go back to the previous question, I'll circle back. You brought up a good point about having people observe and become familiar. And that made me reflect on just basic interviewing and what questions are derived at getting what answers. And I think understanding what the expected outcome of the question or the line of questioning is helps those individuals that are learning how to become investigators, figure out if they're on the right track or not, or how they need to reposition the questionings that they're asking.  

And going back to the most recent question that you asked about legal representation, I think there's also a third situation that more senior investigators might acknowledge as well. And that is when you can notice within your interviewing that the person is responding as if they've already had legal counsel, although they haven't told you that they've had legal counsel and I will circle back to that one at the end.  

Now when you have a situation in which a person is demanding legal counsel, that's again one of those curveballs you say, "Okay, well, we can end this now. Obtain legal counsel. We can reschedule," because you don't want to give the appearance that you're trying to force them to answer questions without legal counsel present and then that's, of course, going to be something that's going to be contentious in the future. So, if they're demanding it, "Hey, no problem. That you're right. Go forward with that. We'll reschedule," and that's kind of an easy one as well. When they show what with legal counsel, hopefully at this point, that this is a serious investigation, you've already consulted with your legal counsel, they're aware of it, and in most of my cases I have them on standby just because of the sensitivity of the matter.  

So, if they show up with counsel, I already got them on speed dial or quick e-mail and say, "Okay, thank you for bringing your lawyer, blah blah blah! Legal counsels are on their way, we can wait 10 minutes and we can restart this," and that gives level playing field. But I also think that it's important to do that preliminary discussion with your legal team so they're not caught off guard and they are also prepared because again, you've got people coming to these meetings that are trying to fight for their lives professionally for their integrity, their position in the industry and all those things are happening at once.  

And to circle back to the last one I brought up and I'm sorry to kind of cut you off there, but there once you've been through those situations, you notice how people omit things from their answers.  You notice how they behave in their mannerisms.  

And an example of one of those things is I had an individual that decided he knew he was wrong. He consulted with counsel, didn't tell anyone, and he ensured that no one else that was on the research team was available. He took them off the schedule that day. They had a previous engagement. He was deferring to them as the primary people doing the things that we had the questions about that had the most serious consequences. And then following that, we have to also understand that we can only penalize people that are in our organizations. He went through as much as possible, then he went forward and resigned, therefore minimizing the impact and allowing him to go forward and restart his career someplace else if he chose to down the road, without any repercussions.  

CJ: Yeah, that's really interesting. And I'm glad you kind of outlined all that because that was going to be one of my questions is if somebody says they want legal counsel or you know they're coming in, it's almost always a given then that you guys are on your side of the table it's going to have legal counsel. I can't think of a scenario where a compliance professional might proceed with an interview with the interviewee having counsel but the compliance professional not, is that accurate or are there scenarios where you might proceed? I can't think of any.  

Eric: There's only one and it's a huge outlier and that would be when the compliance person also serves in the legal role for the organization, which it shouldn't do. But a lot of times that is the only situation in which that person has the expertise from a compliance standpoint and the legal standpoint to represent the institution.  

CJ: Yeah, that's a good point. You know, before you were talking about and I wanted to circle back to this cause it made me think you were talking about kind of questions and the right questions to ask. How did you obtain your experience?  

I know that some organizations like the SCCE and the HCCA, they have workshops on how to be good investigators and interviewers. There are books on it, there's training that other agencies go through. I worked with an individual who was an ex-FBI agent and they're training there made them very good at interviewing people.  

How did you get your training? Do you have any formal training or was it mostly on the job or a mix?  

Eric: Well, in addition to the baptism by fire, ORI; Office of Research Integrity, used to have what they call the boot camp. And that boot camp allowed you to go and work with FBI people like you indicated, former lawyers, or current lawyers, individuals within the federal government that all dealt with serious cases of research and misconduct.  

And although the focus was research misconduct with strategies and objectives, excuse me, the strategies and techniques you were learning could apply to any type of investigation when it came to assessing mannerisms and body language. Understanding the technological components and most importantly, knowing what you don't know so you can go get the expertise so that you don't do a disservice to the investigation.  

CJ: And what you just said about technological, it just made me think, nowadays a lot of employees are working from home and stuff. Have you ever done interviews, like over the phone or via Zoom or something instead of in person, or have most of your interviews been in person and is there a pro or con either way? 

Eric: There are pros and cons to everything. I had one during COVID in particular in which we couldn't really interact with people and that was different because instead of a person's emotion showing, they would just turn the camera off. So, there are ways to circumvent, allowing people to see your responses to the questions, if you appear rattled, or you can see you might want to veer away or dive in a little bit more. Being in person for some people is uncomfortable, so they are more comfortable online.  

So, it depends on the situation, it depends on the people. I think I like them better in person. I get more out of it. What you need to do from a technological standpoint is really beef up what the expectations are, like you outlined the parameters earlier, you can't really force someone to keep their camera on or your microphone, so you know they could be saying all kind of stuff with the mic muted and you have no idea. 

CJ: Right! Yeah, I think that you hit it on the head like looking at their reaction to the questions cause so much of communication is nonverbal.  

Eric: Yes, Sir.  

CJ: And I agree with you, I think in person or at least getting a good visual is really important because a lot of our communication is non-verbal and you pick up on cues. So that's a really great point you made.  

Eric, time has flown by, we're getting close to the end here. I always like to give the guests an opportunity to maybe close with any last-minute thoughts if they have any, it can be about investigations. It can be about compliance in general or I don't know who you're rooting for in baseball! I don't know! Any last-minute thoughts for you?  

Eric: Well, I might give one last-minute thought and I also want to end with a quote that I think will really hit home with this. When it comes to investigations, the number one thing is to not get flustered to develop a strategy and work from your strategy as much as you can until you build a comfort level to work off script and do the things we just talked about, assessing body language, so there's nothing wrong with that or having a more senior person with you, kind of like Drivers Ed. I mean, the worst thing you can do, is do this alone for your pride and jeopardize your credibility as well as the organization's liability from not doing it properly.  

CJ: Right!  

Eric: And my last thought, you know, I'm a big basketball fan, I don't know if any of you know a guy by the name of Mahmoud Abdul-Rauf, he said something very simple:  

"Whatever you focus on growth, your thoughts influence your behavior, your behavior forms your character, and your character determines your fate."  

So, as you move forward in compliance, keep that in mind. 

CJ: I love that! that's a great quote. I appreciate you sharing that. Eric, it's been a pleasure having you on as a guest, appreciate your years of experience and your thoughtfulness in all of this.  

Eric: My pleasure. Thank you for having me on the podcast and thank you everyone for listening.  

CJ: And thank you all to our listeners for listening to another episode of Compliance Conversations. If you like these, you know, subscribe, and share with colleagues. We'd love to get the word out if you have ideas for different topics or if you know guests that you just think would be great, let us know too we'd like to meet what our listening audience would like to hear. So, until our next episode, happy Compliance everybody, take care.