Ballad Health resuming cardiovascular surgeries at HVMC following conclusion of review of some post surgical deaths last week

We all know that our cardiovascular program treats many patients who are very sick, have serious cardiovascular damage, and many times, are facing death. The miracles we have performed in saving lives is something we celebrate, because many people today who are alive, with their families and thriving are doing so because of our passion for quality and lifesaving care.

Yet, we cannot save everyone. Unfortunately, the best cardiovascular programs in America do have patients they cannot save, and some patients do succumb to their disease. This is true of our hospital as well.

Being a top-performing hospital means we take each case very seriously. When we lose a patient, our physicians undertake, in partnership with the hospital, a review of ANY patient death, even seeking, at times, outside review by additional experts to ensure we learn everything we can, or to validate that all the proper steps were taken to help the patients. This is a best practice, and is standard in any hospital seeking continuous quality. The laws of our state, and our accreditation standards, are constructed to encourage this very type of review, and the confidentiality of such review is protected by law to encourage voluntary and engaged participation by doctors, staff and any participant in the care of the patient. This process is the essence of hospital quality programs all over the nation, and is very carefully constructed to ensure engaged participation, open dialogue among the practitioners, and, if necessary, the imposition of corrective action designed to protect patients. If there are findings that the standard of care is not followed, there are self reporting requirements to regulatory and accreditation agencies, which ultimately result in plans of correction being required. If physicians or nurses are found to be out of compliance with standards, there are licensure implications for them. So this is a very serious process, and one which Holston Valley and Ballad Health take very seriously. It is designed to protect patients.

Whenever there is a death, or any circumstance that seems out of the norm, the most important thing is to make sure we take all steps to protect patients from harm. Last week, there were post-cardiovascular surgical deaths. What concerned the team was that it is atypical for us to see a cluster so close together. This does NOT mean anything was wrong with the care. But, as any high quality organization would do, the team, including the physicians and staff, felt it was important to elevate this issue voluntarily. We did so. Ballad Health deployed its quality support team, infection prevention team, and corporate resources to assist Holston Valley in reviewing the situation.

Ballad Health, with the concurrence of Holston Valley physicians and staff, began a review internally. As early as Tuesday morning of last week, Ballad Health notified the Tennessee Department of Health and Centers for Disease Control to inform them of our review. The Tennessee Department of Health, and the local Health Department, at Ballad Health’s request, deployed a team, including epidemiology, pharmacy, and other support, to work with our physicians and staff to conduct a very in-depth review. Again, there was no indication anything was done wrong, other than the timing of these outcomes being so close together. The technical, scientific and clinical expertise of the Department of Health and the CDC was incredibly helpful to our internal teams, and also served to validate our process.

Ballad Health leadership notified the Board of Directors of Ballad Health, and also notified the Commissioner of the Tennessee Department of Health. So, at the highest levels, Ballad Health’s governance was made aware, and our regulator was made aware – because Ballad Health’s leadership was committed to transparency while this process was conducted. It was important for us to have the facts as quickly as possible, so we could act in the interest of patient safety in the event anything were found to be systemic or that would affect patient care.

Concurrently with conducting this review, our physicians, staff and Ballad Health leadership agreed it was the right course of action to cease all surgical procedures while this review was occurring. This is what our patients would expect from an organization devoted to their safety.

After several days of intensive and clinical review, laboratory testing, staffing reviews and evaluation of the environment of care, Ballad Health, along with state and federal experts, reached the unanimous conclusion that none of small number of recent patient outcomes occurring in Holston Valley’s cardiac program were the result of any infection or any systemic issue. In fact, all investigators agreed that these outcomes were not in any way clinically related and could find no causal factors that would lead anyone to believe the standard of care was not followed. Patient records were reviewed extensively, and over several days, every aspect of care was reviewed. The ultimate conclusion is that the outcomes were not outside the scope of what would be expected based on the severity of the patients’ illnesses.

On the basis of these clear findings, we will resume regular cardiac cases on Monday.

Our cardiovascular team will continue, as it always has, taking patient safety seriously, and investigating any outcome that is not what we hope. We wish we could save everyone, and we try to. But sometimes, there are limits to what even the best surgeons and clinical teams can do.

I am very proud of our team for doing what best practice would dictate. We stopped everything, asked questions, brought in outside expert help to make sure we did not miss anything, and we acted with total transparency in the lawful process of conducting case reviews. This very process should give comfort to our community that we take their health and their safety seriously.

I want to comment on something that is deeply concerning to me, however. It is disheartening that this process was undermined by a person, or people, who chose to violate the sacred trust of of this process by sharing confidential, invalidated and inaccurate information with people outside the organization. Doing so only served to frighten people and harm the integrity of this institution.

The lives of our patients depends upon the proper deployment of our mortality and complication review process. The law and our accreditation standards depend upon this process being respected. The process depends upon people feeling they can speak up through proper channels when they see a problem, so the problem can be investigated. How can people depend on this process to work if it is undermined by a person, or people, who would take it upon themselves to communicate inaccurate, invalidated and false information publicly? I can think of little that does more to undermine the good faith efforts of our exceptional physicians and clinical staff – who have worked so hard to create such a high quality and internationally acclaimed heart program.

The damage this can do to the reputation of our heart program and to the public’s confidence, is serious. In this particular case, Holston Valley and Ballad Health did exactly what anyone would expect a health system would do to protect patients. Had there been a systemic issue, we would have taken the appropriate action to communicate that to the families of the patients affected, to our team members, physicians, the public and to our regulators. In this case, our regulators were already in the hospital conducting the review by our side – at our request.

Instead, there is an individual, or individuals, who chose to take matters into their own hands, and they shared information outside the organization that was not accurate, and potentially damaging – not only to our hospital, but to the families who may have lost loved ones to a terrible disease whom the evidence shows we did our best to help. This action undermined the professionalism and expertise of our clinical staff who have worked so hard to build a high quality program, and flies in the face of every evidence-based best practice designed to deliver the highest quality of care. This information was then irresponsibly shared on social media and false information was spread through that venue.

I want to be clear about this: This is not tolerable, and steps will be taken to identify who violated our policies, and maybe even the law. We will seek to hold anyone accountable who spreads misinformation about patient care, and we will do so unapologetically. I have spoken with the leadership of Ballad Health, and they are in full agreement with my concern, and any actions necessary to bring this to a conclusion. If you are the person or persons who violated the trust of this process, the respectable thing to do would be to step forward, and take responsibility for your action. I would encourage you to do this.

Most importantly, to those of you on the surgical team, patient care floors, and to our physician partners who all participated in this review, acted with integrity, and focused on what is best for our patients, you have the absolute gratitude of the Board and leadership of Ballad Health, our management team, and most of all, our patients who are relying on us to keep focused on doing the right thing.