Inside Oversight

Adam Roy
Welcome back to another episode of Inside Oversight, an official podcast of the VA Office of Inspector General. This is your host, Adam Roy.

Today, we’re talking about culture of safety.

According to the Joint Commission, an independent, not-for-profit organization that accredits and certifies US healthcare facilities and programs, including the Veterans Health Administration’s healthcare system, a culture of safety within a medical facility is a reflection of all staff beliefs, attitudes, and priorities in sharing responsibility in minimizing harm to patients as a result of patient care.

The VA’s National Center for Patient Safety, or NCPS, says a necessary component of a culture of safety is a just culture. Just culture describes an environment where VA employees are able to report medical errors without fear and all employees assume accountability for reporting safety issues.

But what happens when a facility’s Patient Safety Program fails to comply with patient safety processes and procedures, or doesn’t follow standard practices such as completing mandatory reports on incidents? Or when leaders fail to hold staff accountable or take action to resolve safety-related issues.

I have Amanda Newton, an associate director with the Office of Healthcare Inspections, here to help me answer those questions and more as we discuss an OIG report we published this past February.

Amanda is a certified safety expert with a wealth of experience looking at medical facilities and the implementation of patient safety programs. She recently was part of a team that completed a healthcare inspection of the Tuscaloosa VA Medical Center in Alabama, where she and her team identified patient safety program deficiencies and a lack of oversight by facility leaders.

Amanda, thank you so much for joining me today. How are you doing?

Amanda Newton
Hi, Adam. I’m doing great. Glad to be here.

Adam Roy
I’m glad to have you, too. Also, for reference, listeners, we’re going to be talking about the report Deficiencies in the Patient Safety Program and Oversight Provided by Facility and VISN Leaders at the Tuscaloosa VA Medical Center in Alabama. Amanda, before we get into the details of that specific report, can you share your experiences as a patient safety expert? What makes your work so unique?

Amanda Newton
Sure. Before coming to the OIG, I actually worked for the US Army as a civilian in a military treatment facility. My last four years there, I was the facility’s patient safety manager. As the patient safety manager, it was my job to lead the development and sustainment of the facility’s patient safety program. Even though I was the patient safety manager whose job really was the lead of the program, patient safety is really a shared responsibility among all of the staff in the healthcare facility. In our work in patient safety, as patient safety experts, is unique because we work with not only the staff at the lower level but the facility leaders and really everyone to create that shared sense of responsibility. And it’s that that’s critical to developing that culture of safety that you mentioned in your introduction.

And what does that mean? Why is that important? Well, first and foremost, it means that there’s this organizational commitment to address safety concerns. And that means that we as an organization were aware of where there’s areas that are high risk. And we’re determined to achieve consistently safe operations. We work together collaboratively. So, that means everyone works together, and its regardless of your grade, your position, your discipline. We work together to find solutions to those patient safety issues. And most importantly, like you mentioned earlier too, work to create the blame-free environment where staff are able to report errors without feeling the fear of reprisal or reprimand. And as you can imagine, this is a huge task. It’s a challenging task. Healthcare organizations are very complex. And, you know, the mistakes that we make actually impact our patients. So, there’s really no margin for error here. And there’s many things that are essential to creating patient safety within the VHA. And that’s everything from tracking and monitoring and reviewing these patient safety events as they occur, compliance with VHA requirements, ensuring that we’re supervising our staff, oversight by the VISN leadership. Lots of things are a part of it, and I’m excited to get to talk to you more about some of these things today.

Adam Roy
Thank you. That’s an excellent overview. Let’s get into the report a little bit. What events led the VA OIG to conduct this specific healthcare inspection?

Amanda Newton
Sure. In September 2021, another OHI team was onsite conducting a separate healthcare inspection at the Tuscaloosa facility. And while they were there, this team received a copy of what’s called an issue brief. And this is just a tool that’s used by facility leaders to sort of provide information up the chain of command, from the facility up to senior leadership of VHA. And usually, they use them to tell about a significant event. This can be something like a death or another unusual incident. If you remember, I spoke about one of the things essential to patient safety within VHA is this idea of insuring that we’re complying with VHA requirements. Well, this issue brief from September 2021 that was sent from facility leaders up to the VISN 7 leaders actually identified there were several areas where the facility’s patient safety program was not meeting this VHA requirement along with some other potential issues with the program. And some of the things that were included were some failures to complete reporting of patient safety incidents within the required timeframe. There were failures to complete required number of patient safety analyses. There are also issues with the facility’s former patient safety manager not attending committee meeting related to patient safety. And it was due to the potential impact to patient safety of these deficiencies that were identified by the issue brief that the second inspection was initiated. And that’s the inspection report that we’re discussing today. , during that inspection, our team identified some other concerns. Those were concerns related to facility leaders and VISN leaders oversight of the patient safety program along with the facility’s culture of patient safety.

Adam Roy
So, you have the issue brief, and that led to the report we’re talking about today. From the report, I understand there’s quite a documented history of patient safety program concerns. Can you elaborate a little bit on that as well?

Amanda Newton
Sure. These issues were even more troubling because the facility was on notice actually from our prior OIG work and our prior OIG inspection. So, the OIG had published what’s called a Comprehensive Healthcare Inspection Program or a CHIP, report back in 2019 that had identified similar issues related to compliance with a patent safety program requirement at the facility. That report made recommendations for improvement. And then there was actually another subsequent inspection in 2020 that found no evidence that the facility had resolved those prior recommendations that had been made.

And so unfortunately, our team actually found the issues that these previous CHIP inspections had identified had remained unresolved at the facility when we were there. And I’ll talk more in depth about that later.

Adam Roy
Gotcha. This report’s really going to focus on VHA’s Patient Safety Program. Before we get into the specifics of this report we’re here to talk about, can you share the program’s goal? What is the goal of the Patient Safety Program? And describe its approach to improving patient safety and ultimately creating a culture of safety.

Amanda Newton
So, one thing that I want to note that’s kind of exciting is that since the publication of this report VHA has actually updated their Patient Safety Program directive. This is the directive that’s going to outline the goals of the patient safety program, the requirements of the program, and provide all of the guidance to the facilities for what they’re supposed to do related to patient safety. This is something we have been waiting on for a while. That’s been recently updated, but the program’s goal and objectives really remain the same. They haven’t changed that much.

And some of those we already mentioned. We talked about the creation of a culture of safety. You mentioned the idea of a just culture. But there’s also a focus on what we call the principles of high reliability or high reliability organization. High reliability organizations are those who experience fewer than anticipated accidents or events of harm. And this is despite the fact that they are highly complex and high-risk environments. So, when you think of a high-reliability organization, you can think of the airline industry or the nuclear industry. They’re very high risk—if there’s something that goes wrong, it’s going to be catastrophic, right? Lots of people are going to be hurt. These industries have implemented principles that help to strengthen their processes and their procedures to create that culture of safety. They also focus on ensuring that their staff feel supported and like they can speak up if something goes wrong. And so VHA’s Patient Safety program is taking a similar approach to reducing patient harm and striving to become a high reliability organization. And the processes that are set forth in this new directive outline a lot of elements that help to not only to foster a culture of safety but to drive the organization towards becoming a high reliability organization. And these are going to be things like we mentioned—reporting events when they occur and ensuring that we are reviewing and analyzing patient safety events to make sure that they don’t happen again. And that’s really the main goal and objective of the program—that we’re identifying what can go wrong that can harm our patients so that we can put things in place to ensure they don’t happen again.

Adam Roy
Excellent. The Patient Safety Program employs a couple critical elements. One is the Joint Patient Safety Reporting System and also root cause analysis, both of which this report describes in detail. Can you talk about those? Let’s start with the Joint Patient Safety Reporting System used to document and track patient safety events. Can you describe how this system works? Who in the facility interacts with the system?

Amanda Newton
Sure. The Joint Patient Safety Reporting system—we call it the JPSR—is actually an electronic patient safety reporting system. It’s like a database/electronic report that any staff can go in and use to report patient safety events. And this can be everyone, from housekeeping staff to the facility director can use this system. It’s used to report things like medication errors, patient falls, wrong site surgery, any patient event that could be something that actually harms a patient or has the potential to harm a patient. It’s kind of interesting, just a side note, it’s called the Joint Patient Safety Reporting system because the system was first implemented by the Department of Defense, and VHA later joined with the DOD to use the system together. It was actually the same system I sued when I was a patient safety manager with the DOD. And as patient safety managers we use the JPSR to review and follow up each reported patient safety event. Patient safety mangers will take a look at the event when its recorded. They determined whether there’s further action and further review is required. Sometimes they will enlist the assistance of additional facility staff to investigate patient safety events. And once that review and investigation is complete, the patient safety manager will again take a look at that report and then close it out in the system. And VHA has a requirement that those events are completed closed within the system withing 14 days of being reported. That’s so we can assure that we are reviewing events timely and acting upon it in a timely manner.

Adam Roy
Yeah. How does the root case analysis, the deployment of that, fit into this process?

Amanda Newton
Sure. When those events get reported in the JPSR, depending on the severity of the event and the type of the event, they may trigger something that we cause a root cause analysis. A root cause analysis is a type of a patient safety analysis where we go back and we look at an event after it occurs. It’s what we call a reactive or retrospective review. We use root cause analysis—we also call them RCAs—to identify those factors that either caused or contributed to the patient safety event. As a part of a just culture—we talked about a just culture—we want to make sure that we’re not focusing on just an individual’s failure, But we want to look at how the system itself failed because really more often than not , when an event occurs or an error or mistake happens, it happens not because a single person made a mistake but because the system itself wasn’t set up in a way to help prevent that error from occurring. So, we look at what processes were absent. What checks and balances weren’t there.

For example, if there’s a medication error that occurs, we’ll go back and we’ll look to see in the RCA if there was a system in place that could have prevented that error from occurring. Some of those things that could be put in place to prevent medication errors are things like bar code scanning. If you’ve ever been at the hospital and seen the nurse scan your arm band and scan a medication, they’re doing that to ensure that they’re giving the right medication to the right person. There are also systems like automated medication dispensers. Those are systems that we can put in place to prevent humans from making mistakes. AND RCAs help us to identify those fixes that we can put in place. Once we’ve reviewed an event with an RCA and determined what went wrong—and those things that go wrong, we call these root causes—we implement those corrective actions that hopefully prevent events from happening in the future. So that’s the root cause analysis process.

Adam Roy
Absolutely. Thank you. And looking at this Tuscaloosa report, it focused on a patient safety manager, an individual who had to work within the patient safety program, within the system. Of course, there were some challenges there. Your team found some deficiencies and challenges, some actions that the patient safety manger took. Can you get into a little bit of that. Describe some of the challenges that this patient safety manger was facing and then also maybe just challenges that the system created that didn’t help that patient safety manager do his or her job correctly or proficiently?

Amanda Newton
The former patient safety manager there at Tuscaloosa had been in that position for quite some time and had retired there in September 2021. It was at that time that the facility discovered the deficiencies with the facility’s patient safety program. I’ve mentioned several times now the VHA requirements for patient safety programs and the importance of ensuring compliance with those requirements. One thing that I’ve mentioned is that patient safety managers should close out JPSR events within 14 days of submission. Our patient safety manager, by the end of their tenure there are Tuscaloosa was failing to meet that 14-day requirement for closing JPSRs. When our team spoke with the former patient safety manager, they described a very strong history of staff reporting. Staff were reporting events in the JPSR system. There was a large number of reports that came in, but the patient safety manager reported and acknowledged that there were times where events in the JPSR were incomplete and may not have been finalized timely. They attributed that to some challenges of managing just the workload of the volume of events and explained to us that facility leadership had not supplied some additional staffing resources that had been requested to support the program.

Also, remember I had mentioned that patient safety managers can assign or ask other staff to help with investigations with JPSR events. We call these investigators. The former patient safety manager also told our team that there were some challenges with investigators, and there were challenges working with frontline staff in the investigation process to resolve issues or really to just resolve the JPSR documents themselves. This sort of led to prioritizing resolving the issues themselves over ensuring completion of the documentation in the JPSR. That kind of led to this abundance of incomplete JPSRs. Also, the former patient safety manager had not met the annual requirement for RCA. There’s a requirement that there’s a minimum of what we call a minimum of eight patient safety analyses that are completed annually. This can be a combination of things. One of those things is an RCA. When we spoke with the former patient safety manager about RCAs, they shared that completion of RCAs was impacted by the challenges of putting together an RCA team, and that there were delays in getting completed RCA paperwork back from the facility director. That led to getting, again, prioritizing getting the patient safety issues resolved over completing the documentation.

One last thing that I’ll note is that the former patient safety manager also told us that they believed that supervisors didn’t fully understand the demands of their job and didn’t fully understand the demands of the patient safety program. That kind of resulted in a feeling of lack of support and engagement with the program.

Adam Roy
That’s a good point and a good way to transition from talking about the patient safety manager to talking about the facility leaders. I heard you mention there that there was maybe an emphasis on just closing the actions to meet a timeline due to workload versus fully completing all the requirements of a safety incident. Where were the facility leaders in this process? Obviously, they were aware of the workload, but how are they communicating this up possibly to the VISN or VISN leadership or communicating it down to medical facility staff? How did facility leaders respond to that initial issue brief and what actions did they take or possibly fail to take?

Amanda Newton
The good news is that facility leaders did act to address those concerns and issues that were brought up in the issue brief. We learned that they took steps immediately to improve compliance with VHA requirements. This is to get those JPSR events resolved and completed, and they did provide us with evidence that that had been taken care of in November 2021. They also took steps to ensure that any overdue or outstanding RCAs were completed for that fiscal year. Our team was provided the documentation that we reviewed to ensure this was completed.

But one thing that our team looked at was who at the facility had awareness of the failures of the patient safety program. It is kind of a who, what when, where thing. Who could have stepped in sooner? Who could have acted on addressing these issues or identifying these issues? As a part of this, we assessed the supervision of the former patient safety manager, and we also took a look at the facility reporting structure. We found that the supervision of the former patient safety manager was ineffective for a few reasons. We learned that former supervisors of the patient safety manager lacked access to some of the programs used by the patient safety program. The JPSR was one program. There’s also a program called WebSPOT that’s sued as a database for RCA. Former supervisors didn’t have access to those systems, so they couldn’t actually go into the system and see in real time what was the statuses of JPSR events. What were the statuses of RCA? Were they overdue? Were they outstanding? They didn’t have the ability to have oversight of the former patient safety manager’s workload when it came to patient safety reports and RCA.

We also learned through speaking with supervisors and looking at personnel records that the former patient safety manager’s supervisors were aware of performance issues. These are issues with incomplete RCAs that were identified in those OIG CHIP reports that I had mentioned earlier. And there were no formal performance improvement plans implemented to address those issues or bring things up to compliance that we could find.

We also spoke to supervisors, and they described this approach as trusting but verifying when it came to what the former patient safety manager reported to them either directly or in meetings. That kind of leads into the next thing about the oversight system at the facility not being effective. When the framework for the patient safety program—it’s that it’s embedded and integrated into many of the facility’s activities. This includes everything from the reporting of events that I mentioned to various hospital committees that work to plan and kind of organize patient safety across the facility. So, we learned that there were several areas where the patient safety manager reported patient safety events and program requirements, but supervisors and leaders just sort of trusted the word of the patient safety manager and didn’t verify that these things were getting done.

Adam Roy
In the omission of oversight and as you look at the VISN for that facility and the overall VHA policy, was the VISN patient safety officer aware of the delays and the issues with the JSPR and some of your findings? Was anything done? And what is really their role there beyond just oversight?

Amanda Newton
The VISN patient safety officer has a responsibility related to overseeing patient safety programs throughout the VISN. For Tuscaloosa, this is VISN 7. The patient safety officer is really uniquely positioned to identify these issues. They actually have access to the JPSR system used for patient safety events. They have access to WebSPOT used for RCA. This is unlike the former PSM’s actual supervisors at the facility. The VISN patient safety officer can go into the system to see are JPSRs overdue. Are RCAs outstanding or incomplete? We learned that the patient safety officer was aware of times when the former PSM was overdue in JPSRs from time to time and would prompt the former PSM to bring those up to compliance.

The 2019 and 2020 CHIP reports I mentioned that had the reported RCA deficiencies—the VISN PSO certainly, as a VISN leader, was aware of those CHIP reports. But we really couldn’t find any evidence where that information was taken or that data was used to proactively to identify issues and address deficiencies with RCAs at the facility. We also learned that, like the facility, the VISN has a committee that’s responsible for oversight of patient safety within the VISN. This committee is made up of patient safety managers from facilities all across the VISN. They look at JPSR event trends. They look at RCAs. And we review the minutes from this committee, and we found that they really lack evidence of regular discussions related to facility-level compliance with VHA requirements like JPSR and RCA.

Adam Roy
Like you mentioned earlier where you said that a culture of safety or an effective patient safety program just doesn’t rest of the shoulders of one individual. It really does rest on the entire staff to include leadership at the facility level and, as you just spoke to, at the VISN level. Is that a fair assessment when you look at this report and you think about the things that this facility and maybe VHA can do better? It really comes down to leadership accountability and everyone leaning in and addressing these leadership issues versus, I guess you can say, passing the buck.

Amanda Newton
Yes. It really does. Certainly, we can trust the staff that work for us. But as leaders of organizations, we really do have to verify that our programs are in compliance. And the responsibility of that lies at every level. Going to back to the beginning of our conversation, I said patient safety is responsibility of everyone. That really is from the frontline staff at the bedside all the way up to the VISN network director. There’s layers of responsibility there. This case is really an example of holes in the layers, holes in oversight where the oversight wasn’t strong enough to catch these mistakes from happening. It just sort of allowed these deficiencies to continue.

Adam Roy
That’s an excellent summary. In the report, your team made 11 recommendations related to determining which patient, safety event reports the VISN patient safety officer will review, the role of the Patient Safety/Risk Management Subcommittee, as well as timely completion of safety event reporting and feedback to those employees who make the report. Better overall program oversight and accountability by all employees were also recommended. What is the status of those recommendations today and what do you hope to see next?

Amanda Newton
Of course, VHA continues to work on the recommendations. One of our recommendations—and this was recommendation number 5—was actually made to the under secretary for health. We asked them to review the current processes used for providing access to the JPSR system and to the WebSPOT system used for RCA to determine whether there were specific staff positions that would benefit from automatically receiving access to these databases upon being hired to the position. We felt it was important for VHA to look at that because of the issues we identified with the former patient safety manager’s supervisors being unable to provide that hands-on oversight of the work in these systems because they didn’t have access to these systems.

VHA did review that. They provided information back to the OIG that they reviewed the process and determined that granting automatic access would not be appropriate due to some data integrity concerns. In conversation with our OIG leadership, the determination was made to go ahead and close that recommendation.

Adam Roy
Excellent.

Amanda Newton
Yeah. So, our other recommendations remain open at this time. And our recommendations really highlight ways that the facility can strengthen compliance with their patient safety program requirements. Things like the JPSR requirements, RCA requirement that we briefly talked about. Of course, after receiving the report, VHA responded back with an action plan to address those recommendations. We as the OIG continue to monitor the status of those recommendations and, of course, have frequent follow-up with VHA to monitor their response.

Adam Roy
Absolutely. I really enjoyed speaking with you today. Is there anything you want to add before we wrap up?

Amanda Newton
I would just add that this report details deficiencies at just one VA medical center. I think it would serve as a cautionary tale to other facilities throughout VHA. There’s lessons learned here that we can certainly apply to other facilities. I really hope that other facilities’ staff, other facilities’ leaders can take the information here and use these lessons to ensure the strength of their patient safety program.

Adam Roy
That is a really good point, and I appreciate you sharing that. Thank you again for your time today, Amanda. That was excellent.

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