Hello, I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars With Researchers. Today we’re going to talk about site level workforce issues and I’m going to leave you with 3 basic chapters in this episode. First, we’re going to talk about CAPA – Corrective Action and Preventive Action. Secondly, we’re going to talk about how to appropriately intervene when you have a site level workforce issue and then lastly, we’ll talk about what to do if you are the Sponsor, CRO, or Site Director, because frankly they’re all treated the same or should be. The only difference is the depth of resources available.
CAPA: Corrective and Preventative Action
In my opinion, in our industry, CAPA is thought of wrongly and I can see why. It sounds very linear, doesn’t it? 1) There’s an issue. 2) I diagnose what the issue is. 3) I put in a corrective action to fix what happened today. 4) I put forth a preventive action that should prevent the issue from happening again in the future. Done, linear, finish line. But that’s a fallacy, not reality. And it’s ironic because we’re in research and, in research, the whole point of what we do is circular. We think, “this is going to be the next great treatment for Type 2 diabetes.” So we plan, do, study, act, plan, do, study, act, Phase I, Phase II, Phase III. We might have to change the dose that we thought was going to be the right. As opposed to linear, where we know: we put an action in place > finish line. With research, we can constantly improve. So, we must change how we think through issue resolution. Yes, you have to do CAPA, but we have to stop thinking about it as a finish line and we have to start thinking about it in a normal change management framework of plan, do, study, act.
How to Intervene
When you have a site level workforce issue, something has gone bad at the site; some protocol deviation, some issue. What do you do about it? I’m confident nearly everybody watching this has had CPR training in their life. In CPR, we were drilled on ABC – Airway, Breathing, Circulation. Even if you know the person just collapsed in front of you because of a heart issue, you still always start with airway. What if they grabbed their chest because they were short on oxygen because they were choking on a piece of meat? So, we always start with airway, then breathing, then circulation, because order matters. If the airway is blocked, then assessing the person’s breathing is a waste of your time. You’ve got to start with airway and if the airway is blocked, assessing the person’s circulation is a waste of your time. In trauma, they actually extended it to A, B, C, D, E.
What I’m going to put forth is that we should always be thinking through site-level workforce issues on six parameters. You could think about it as ABCDE except the letters don’t really matter. In research, we always, always, always start with patient safety. Patient safety is paramount. Patient safety is equivalent to airway. What’s number two? Data integrity – that’s always the first two. Patient safety, data integrity. Anytime you have an issue, our first thought always, always, always should be patient safety. Forget what the issue is that you know – patient safety – we went to airway, then go to data integrity. Is there any bad data that we have to make sure that we flag? Is there anything that we need to look at there? Then you can proceed, and those things only take seconds. Just like assessing the airway, it doesn’t prevent you from getting down to doing the CPR. It takes seconds.
So, then what? Patient safety, data integrity, root cause analysis. Now you’re getting into the plan of PDSA. Plan is root cause analysis. What is the real issue? Is that the issue that I think is before me or was there something deeper, or even more deeper? One of the things you can do is ask the five why’s to figure out why did it happen? And then you get an answer. You can end up getting to a root cause that is so much more meaningful than the superficial cause you previously had before you.
So now you think you have your root cause. What’s your next step? Well, the next step is equivalent to CAPA. What intervention would we make? What is the corrective and preventive action? Based upon that root cause, what could we do to fix it and prevent it? Now, S (study) – you don’t walk away, you don’t assume you’re done. You’re running an experiment. You’ve intervened to help the protocol run better, to help fix the issue, to help prevent the issue from recurring in the future. Now study it. Did the intervention work? Did it make the difference that we wanted it to make? And then act! What did we learn from the study? And now we can reenter that cycle to refine it all that much more. It’s not finite, it’s circular, and we can keep doing that over and over to keep making things better. That’s how you intervene on a site level of workforce issue. A,B,C,D,E becomes P,D,R,C,S,A: Patient safety, data integrity, root cause analysis, CAPA, study what you did, act on what you’ve learned from the study, and keep going.
Sponsor, CROs, Site Directors
If you are a Sponsor, CRO, or Site Director, you should always be doing things this way. Recognize that your sites may not know how to do this. They may not know how to do a real root cause analysis. They may not know how to appropriately intervene. It is in your best interest to think this way and help sites to think this way because they may not be there yet. They may be great researchers, but they may not know how to do change management. They may not know how to do these slightly more sophisticated things to get at the real issues and help then refine policies, procedures, processes and people management to make everything better in the future. Assist them. Go into the interaction from an open framework to help them think through it and make their sites better and then provide the resources that are needed.
If the issue is large (and it’s a research coordinator issue and it’s a meaningful, big, deep issue) maybe the appropriate intervention is to immediately pull resources from elsewhere and replace the research coordinator. Or have a solid backup for the research coordinator where it’s essentially a team of two rather than a team of one. If the site doesn’t have those resources, I find that most Sponsors and CROs have the capability to provide a research coordinator or resource to help the site get over that issue. But you’ll never get that resource if you’ve never identified what the real issue is, or you’ve never been honest about what the real issue is.
To recap, what do you do when you’ve got a site level work force issue?
- Stop thinking about CAPA as being linear.
- Start with patients’ safety, then data integrity, then root cause analysis, CAPA, study what you did, and act on what you learned from the study.
- Sponsors and CROs – train your CRAs and project managers to think this way so that they can interact with the sites in the same way.
In so doing, we’ll elevate our entire industry. We can change how we think through these issues and elevate our performance so that, incrementally, we’re better, and better, and better. Month, after month, after month. Year, after year, after year.
Thanks for riding along!
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