How One Health System Leads on Ethical Management of Never Events

About The Leapfrog Never Events Policy

Leapfrog defines Never Events in alignment with The National Quality Forum (NQF) consensus-based list of 29 events termed “serious reportable events.” These are events that should never occur, such as surgery performed on the wrong body part or on the wrong patient, leaving a foreign object inside a patient after surgery, or death or serious disability from the wrong blood type, certain devices, or contaminated drugs.

Unfortunately, Never Events do happen. Beginning in 2007, The Leapfrog Group asked hospitals to commit to five actions if a Never Event occurred within their facility, and purchasers and payors across the country have agreed to incorporate the Leapfrog Never Events policy into payment principles and contracting. The five original actions include (1) apologize to the patient; (2) report the event; (3) perform a root cause analysis; (4) waive costs directly related to the event; (5) provide a copy of the hospital’s policy on Never Events to patients and payors upon request.

Inspired by pioneering work at Medstar Health, in 2017, Leapfrog expanded its original Never Events policy by asking hospitals to commit to four additional actions: (6) interview patients and/or families to gather evidence for the root cause analysis; (7) inform patients and/or families of actions taken to prevent reoccurrence of the event; (8) provide support for caregivers involved in the event; and (9) perform an annual review to ensure compliance with each of these elements for each event.

Medstar Health, a 10-hospital system in the Washington D.C. and Baltimore area, developed an ethical approach to working with patients and families in the wake of a Never Event occurrence, and their program was adapted to develop AHRQ’s CANDOR (Communication and Optimal Resolution) toolkit.

CANDOR aims for a paradigm shift in two ways: It turns caregivers from the “delay, deny, and defend” approach which persists in many health care systems to early communication with patients and families. This increases transparency and decreases the emotional pain experienced by patients and their families when they lack information. Secondly, the CANDOR program addresses flaws in the traditional Root Cause Analysis (RCA) system. It moves towards science-based event review programs more likely to result in effective and sustainable systems improvements.


Interview with Medstar Health System Leaders


As seen in the following video and written transcript, Leapfrog President and CEO Leah Binder interviewed Terry Fairbanks, Vice President and Chief Quality & Safety Officer, and Kate Kellogg, Assistant Vice President Quality & Safety, at Medstar Health in Maryland and Washington D.C. about their work on CANDOR.




Binder: Medstar Health is a national leader taking an ethical approach to patients and families in the wake of Never Event occurrence. Medstar Health developed the Communication and Optimal Resolution process, also known as CANDOR, with AHRQ, the Agency for Healthcare Research and Quality. Your leadership and vision has informed Leapfrog in our journey to create a standard in the highest ethical treatment of patients. Can you give a brief overview of this work for those who aren’t familiar?

Dr. Fairbanks: Thank you for having us for this interview. We really appreciate Leapfrog’s leadership and focus on safety. We are proud that we took our human factors systems-based approach to event review and combined it with risk management’s approach to early communication with patients and families, and worked with AHRQ to develop CANDOR. Larry Smith, Our Vice President of Risk Management has been doing early disclosure with patients’ families throughout his career. So it’s been a natural fit to combine his work with our work in event review. Dr. Kellogg and her team oversee CANDOR, so she’ll talk about a few key areas of this process.

Binder: You said that CANDOR came about through a partnership between the quality and safety team and your risk management team. That is very impressive.

Dr. Fairbanks: That’s right. CANDOR actually has many pieces to it, but we are talking about the safety event response piece of the program. This is something that hospitals cannot do well unless safety leaders and risk management leaders are both fully on board.

Binder: That’s an exciting partnership, especially that risk management can lead on something that is truly bold.

Dr. Kellogg: The first area of CANDOR is early reporting and really making sure that the safety and risk management team know about the event and can activate the team for response. And that the team can work together to have early communication with the patient and the family as appropriate. They let them know that an unexpected event occurred and that they are looking into it to learn exactly what happened. Then we can start right away with a systems-focused event review to get the details that sometimes get lost if you don’t start for a few weeks. The other really important thing is to care for the caregiver. Sometimes it’s the worst day of your life as a caregiver so we aim to get there quickly so we can support them and our patients and families early.

Binder: It’s also really important to do this publicly. You need to convey to your entire workforce that you care about them and understand that health care is very hard work. Organizations have to come together to support the caregiver.

Dr. Kellogg: That’s right and other peers are watching to see what happens even if they weren’t involved. If they see others blamed and shamed, they are going to be much less likely to report events in the future and to ask for help if that’s what they’ve seen in the past. We’ve also seen health care workers leave health care and even commit suicide after being involved in these events. There is a major culture and safety piece involved in being there for your people.

Binder: We want Never Events to truly be never, so take me through what happens in the CANDOR process?

Dr. Kellogg: This is the process we use for Never Events, but we use this process in response to any serious unanticipated outcome. Sometimes we don’t know right away if it was an error or not so we need to start the CANDOR process. We tell our team that any time a patient or family or someone on the care team think that something unexpected has happened, that’s the time to activate the process and to report. Even if it turns out to not be a serious safety event, we can almost always learn something and gain something, and we can be there for the patients and families to help them understand what happened. If we do have an event occur, the risk management and safety teams get called right away by the surgeon, a circulating nurse, or really anyone on staff. This is often a phone call or page that activates us. Right away the most important thing is to care for the caregiver and to make sure the team knows we are there to understand what happened and not to figure out whose fault it is. We need to get in touch with the patient and family right away to let them know transparently what is happening and what our process is. Sometimes the patient might need an escalation of care or need something to decrease the negative effects of the event on their health. We can help facilitate that rapidly. We work together in all of this with risk management so they are in the loop and then we start the event review. For example, if there is an oxygen tank that ran out that tank might get sent downstairs to get refilled and we may never know if it was actually out of oxygen or if it was on low. If our team is there, we can sequester the tank and that’s part of the review. Sometimes telemetry strips on the floor get thrown in the trash, but if we are there, we can collect the information and get the event review started early so we can truly understand what happened.

"You need to be transparent and tell the family you’ll be honest with them even if it hurts."

Binder: How soon do you apologize?

Dr. Kellogg: We are always straightforward and upfront with patients and families right away when things happen. The apology piece often takes longer to understand what actually happened. We have ongoing conversations with families and a lot of the time we aren’t sure what happened at first. When it’s appropriate and the review shows a need for an apology, we do it then.

Dr. Fairbanks: There are a couple high-level principles that are important here. One is that I think the way it can be done not as well is when a local team takes lot of time to try to figure out what happened and then if they believe something went wrong they start all the pieces like the care for the caregiver, RCA, and communication with the patient and family. We believe that’s too late. One of the fundamental concepts is that if you’re a family member and think something has gone wrong, you are scared and worried and there are trust issues. If you view the health system as being silent at that point, it is a horrible position to be in because that health system is taking care of your family member. We tell our team members to not wait to figure anything out. The moment if think there is a perception that something went wrong, we have to start these conversations to have trust. In order to do that well, you don’t need to know if there’s anything to apologize for. You need to be transparent and tell the family you’ll be honest with them even if it hurts. It’s so important to maintain the trust. Once we finish the event review, we share the results with them and answer their questions. We also often involve the family in the event review. Sometimes they’ve been there and seen things others have not, so we use them as a data point. It does sometimes take time to get to the apology if it’s the right thing. Other times, we bring the family in and explain things even if there hasn’t been an error so they know exactly what happened. The second piece is the care for the caregiver. Nobody comes to work intending to be part of an event where someone is injured, and they just feel awful when these things happen. We want to be there immediately to support them.

Binder: It’s not necessarily human nature to want to be completely transparent and open when there’s been a major error or mistake that’s really harmed someone else and you feel like you’ve had a part in this happening. How do you train and educate clinicians and staff to be part of this and to be transparent?

Dr. Kellogg: Part of this is really hard wiring transparency into our high reliability culture. This is a huge part of how we integrate safety into everything we do. We do things like sharing safety moments during meetings and huddles and sharing good catch moments across the system every week. We try to keep the reporting and supportive culture front of mind for everyone.

Dr. Fairbanks: We have 31,000 associates and they have all had High Reliability Organization (HRO) training where we make sure they understand that safety is our number one priority and empower them to be part of the safety solution. It also lets them know the principles we live by. Everyone on the team, from those who are helping keep the room clean to those keeping us safe in the operating room and every staff member, understands the obligation and Medstar’s approach to this.

Binder: Tell me about a patient impacted positively by CANDOR?

Dr. Fairbanks: There is a great story with someone who has now become a friend, Jack, who had just retired and wanted to play golf more but was having problems with spine arthritis and was referred to one of our surgeons. Because of a series of events that occurred in the operating room, he came out of surgery paralyzed for life. In the middle of the case, the surgeon came out and talked to his wife and told her that her husband is still asleep on the table and told her what happened, gave her options and asked what she wanted to do. He was transparent with her and didn’t need to call risk management. He knew he was empowered to have this conversation with Jack’s wife with full transparency so she could be involved from the beginning. As that case progressed, the health system took the approach that “you came into our hospital and you were injured, so we are going to do anything we can do take care of you.” We don’t ask people to sign a disclosure or a wavier because we know we have a liability and are responsible and we take care of it. As this story goes, Jack’s insurance would have kicked him out of rehab after a month but we covered the costs so he could be taken care of. There are a lot of stories like this of us trying to do the right thing to take care of patients. We’ve flown family members in and covered other costs and other expenses. In the end, from an ethical standpoint, this is the way to do it. Ultimately, our goal as a safety program is to not have these events. The majority of our focus is proactively working to make our complex system as resilient and safe and possible. We’ve done a great job keeping these events to a minimum and we are still working on having none. In the meantime, we have to react appropriately, and all of our stories need to be like Jack’s story.

Binder: Jack is a champion of Medstar now. Instead of facing off in the courtroom, he is a champion and leader.

Dr. Fairbanks: There are many stories like Jack’s and the reason we tell his story is because we have permission to. He tells his own story and it’s important that he shares it personally so people understand what it’s like for a family to go through something like this. Certainly it’s not a pleasant experience no matter how a health system reacts, but what Jack’s been through is a compelling story.

Dr. Kellogg: There are also times when CANDOR helps our caregivers too. We recently had a patient who had a fall in radiology and there was a miscommunication between the nurse and the technician about the patient’s fall risk. The technician was literally sticking her head out the door to call the radiologist in and the patient turned and fell and broke his hip. We initiated our normal process and someone on our team called the radiology tech the next day to check on her and she said “I’ve been a radiology tech for decades and I’ve never been involved in something like this. I can’t believe this happened on my watch and this patient needs surgery. I’m going to put in my resignation today because I’m so distraught.” We were able to reassure her and now she’s a champion for fall prevention in radiology and has told her story throughout the system. She’s been able to embrace her role as a safety champion because of the focus on caring for the caregiver.

Dr. Fairbanks: These experiences make them lifetime safety advocates. People talk about making a safety coach program and we create safety coaches every time something like this happens because people understand, become more vigilant, and feel safe reporting hazards.

Binder: Can you tell me about how you built this culture of transparency? How did you get there?

Dr. Fairbanks: We’re not done yet. We are a big system, so getting to every corner where it happens right every time is a future goal for us. Almost all the time, we do it this way. It is really through what we’ve already talked about – having a constant drumbeat about prioritizing safety. Every leadership meeting and other meeting that occurs has a safety moment and they link these cases to our resilience principles so everyone knows the expectation from this standpoint.

Binder: This is one of the key issues that Leapfrog tries to reinforce. You are never done with safety. You can celebrate accomplishments, but that doesn’t mean you are done. Safety is 24/7 and you can never let up. Sometimes there’s a tendency to focus on a specific goal like improving a certain infection rate and you can get there, but there’s not an end point. That’s a beginning.

"Leapfrog is taking a national lead making sure patient safety remains a critical focus"

Binder: Let me ask you now about the Leapfrog Hospital Survey. What role has it played in fostering your culture of safety?

Dr. Fairbanks: What the Leapfrog Hospital Survey has done is it’s given us many guideposts with which to move forward. It helps us with messaging to leadership and keeps the drumbeat for safety going. We want to make sure everyone in our organization understands the importance of safety. I love that Leapfrog is focused on safety. The quality metrics are equally important, but Leapfrog is taking a national lead making sure patient safety remains a critical focus.

Binder: We appreciate you recognize that. Patient safety is the heart of soul of what Leapfrog’s about.

Dr. Kellogg: The Culture of Safety Survey on the Leapfrog Hospital Survey is a really important aspect for us. This is another piece that helps us evaluate ourselves and our culture. This is how we can get feedback from our frontline workers about how they’re feeling about safety.

Binder: This is really important. We’ve had this on our Survey for 20 years. At the beginning, nobody was doing it and now most hospitals do. It gives critical insights to leaders.

"It has to start at the top. Safety must be the word of the Board and the C-suite leaders."

Binder: What advice do you give to other health system leaders who want to implement something like CANDOR?

Dr. Fairbanks:It has to start at the top. Safety must be the word of the Board and the C-suite leaders. That principle of safety first is integrated into all of our messaging. It must be an organizational commitment. Then you must have a good framework for how to do this and there has to be a partnership between the safety team and risk management. There have to be tools so everyone understands the expectation and how to proceed when there is an unexpected event.

Dr. Kellogg: The CANDOR package on AHRQ’s website is free and I always recommend people start there. Also on the IHI website, there’s the RCA2 resource which is also helpful. It’s also critical to learn from other hospitals who are doing this. A lot of times the best way to learn is to network and learn about how they’ve overcome barriers. We’ve all made mistakes and figured things out so there are many ways to learn.

Dr. Fairbanks: We are part of the Medstar Health Institute for Quality and Safety and have resources available and people able to help as we can. I want to emphasize that one of the things that’s helped us is what Leapfrog does in putting external validation for what we do. By having Leapfrog Hospital Safety Grades, it gives our team members pride when they accomplish these metrics.

Binder: The employers who founded Leapfrog really do value what you do. We want to recognize excellence and ethics. We know it’s hard work every single day to do what your health system does. Thank you for what you do and for your commitment to the safety of your patients and community.

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