Death and Scandal in Pediatric Cardiac Surgery Programs

Close up of pediatric cardiac surgery.

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Death and Scandal in Pediatric Cardiac Surgery Programs:

History, Ethical Analysis, and Recommendations

 

Ian D. Wolfe and John D. Lantos

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ABSTRACT

Over the past few years, several high-profile scandals have befallen well-known U.S. pediatric cardiac surgery programs. The aftermath paints a picture of persistent systemic institutional problems that motivated staff to become whistleblowers. The industry experts point to the lack of regionalization as the problem. Is the cause of such problems the lack of regionalized pediatric cardiac surgery centers? We analyze recent U.S. scandals to contrast and compare them with international scandals and approaches to pediatric cardiac surgery. We review several cases of public scandals and perform a thematic analysis through a bioethics lens. Our analysis of these situations, though limited, suggests that while lack of regionalization is an external factor, many internal problems leading to scandal arise as a result of inattention to organizational ethics, the ethical climate, and widely accepted practices to promote safety. Attention to these practices would have prevented scandal, regionalized or not. We offer well-known organizational ethics principles and strategies and current research into the tenets of an ethical climate to prevent such scandals.

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Across the cardiac surgery scandals reviewed, there was a complete lack of accountability over both administrative and clinical leaders. This ensures that these problems will only be addressed by a more devastating outcome, leak to the press, or constant staff turnover finally becomes too much for the organization to bear.

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Introduction

Over the past few decades, a handful of pediatric cardiac surgery programs have been rocked by scandals. These scandals follow a common trajectory. Some children have unexpected bad outcomes. People within the program voice concerns about the quality of care and whether those bad outcomes were avoidable. Those concerns are ignored. More children suffer, or die. There is a media exposé. Blame is assigned. People leave and get fired. Everyone wonders how this could happen.

The recurrence of such scandals within pediatric cardiac surgery programs suggests that there are organizational problems in the design, auditing, and ethos of programs that have experienced a scandal. In this paper, we examine several of the recent scandals to elucidate the complex factors that lead to these problems. Based on data about the epidemiology of congenital heart disease (CHD), these scandals, in the U.S., are likely to recur; this is due to the current U.S. approach to building cardiac surgery programs and the existing organizational pressures we will discuss.

We suggest that to contend with the factors that lead to scandals requires a commitment to establishing a moral infrastructure, maintaining an ethical climate, and promoting organizational behavior grounded in ethics. We conclude by articulating the ethical obligations that need to be satisfied by both administrative and clinical leadership, and frontline caregivers, in order to build and maintain the conditions to avoid these system failures.

Epidemiology of Congenital Heart Disease

According to the CDC, around 40,000 babies are born with CHD in the US each year, about one out of every 100 births. Some cardiovascular defects do not require surgical intervention. Other “non-critical” defects require relatively simple operations. The most common type of CHD is a hole between the two ventricles called a ventricular septal defect (VSD). Minor VSDs do not cause any health issues and close on their own. [11892 Large VSDs may require surgery to close the defect.

Many other critical CHDs require immediate and intensive surgical treatment. The incidence of critical heart lesions is about 10,000 new cases per year in the US, which constitutes the 25% of CHD that requires surgery. [2] The overall one-year survival rate for babies with critical CHD is about 75%. [2, 3]

Other forms of CHD are immediately life-threatening. The most serious of these critical CHDs is hypoplastic left heart syndrome (HLHS). In HLHS, children are born with essentially one working ventricle, making the heart barely functional. HLHS occurs in one in around 4000 to 6000 live births resulting in 800-1000 babies born with the disease in the US every year. [4,5,6] Babies with HLHS require three major surgeries in the first year or two of life. These surgeries do not “cure” HLHS, rather they are considered “palliative” in that they allow the child to live with an impaired but moderately functional heart; transplant is the only other option. Each of the three operations is associated with some mortality. Nevertheless, most babies with HLHS now survive, albeit with deficits and a shortened life, when treated at experienced centers.

Complexity of Cardiac Surgery Programs

Building and maintaining a pediatric cardiac surgery program is a complex undertaking. One needs expert cardiologists, surgeons, critical care specialists, critical care nurses, perfusionists, respiratory therapists, physical and occupational therapists, psychologists, and other committed child health professionals. The conventional wisdom is that in order for this complex team to work cohesively together, they need to do a high number of cases each year and require a sufficient amount of support and resources.

Several leading organizations support the volume outcome correlation. The American Academy of Pediatrics (AAP) guidelines for congenital heart surgery stress the association between volume and outcome. [7547] The European Association of Cardio-Thoracic Surgery (EACTS) recommends that a pediatric cardiac surgical program should ideally perform at least 250 operations per year and that, to do so, there should be one such center for each population group of four to six million. [8] They suggest that each cardiac surgeon should perform a minimum of 125 cases per year. [8] Sweden, Slovakia, and Slovenia have followed these guidelines and have mortality rates that are among the lowest in Europe. [9,10]

While volume and outcome have been found to be correlated in several types of surgical programs, both adult and pediatric, it doesn’t necessarily explain why some programs have suffered scandals. Certainly bad outcomes don’t inherently lead to scandal, particularly in a specialty that deals with some of the most complex surgical pathologies; not all children will survive their treatment.

Whether these scandals happened solely because of a lack of volume is a reasonable question. It is possible that the programs that do higher numbers of cases provide more attention to team dynamics, ongoing physical, environmental, and educational support and resources, and focus on outcomes over financial pressures. We will briefly review these scandals in chronological order from available information. We will then provide an analysis of the available data on these scandals and proposed solutions through an ethical lens.

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Summaries of Cardiac Surgery Scandals

Winnipeg

In 1994, twelve children died at the Winnipeg Health Sciences Centre after undergoing cardiac surgery for CHD. The mortality rate for high-risk patients at Winnipeg was triple that of other Canadian hospitals. [11] These deaths spurred the Chief Medical Examiner for the Province of Manitoba to order an inquest. [12] The inquest revealed serious problems.

The program at Winnipeg was created in 1975. From the start, its mortality rates were higher than at other hospitals. The program was suspended in 1983. In 1986, a new surgeon was hired to rebuild the program. The numbers of patients stayed relatively low. The physicians there felt that they didn’t have the resources that they needed to provide what are now considered basic cardiology services. [13]

In 1993, that second surgeon left. The hospital hired another surgeon who had just finished training. That third surgeon didn’t seem to have the skill or experience to run a program by himself. He had never operated independently before and had no surgical mentor at Winnipeg. Nurses raised concerns about issues in the operating room including his technique in preparing children to go on heart bypass, the amount of blood lost in that process, and the amount of time they spent on bypass. [11,12] The nurses were ignored, and surgeries continued. The relationship between the surgeon and the nursing staff became adversarial. Eventually, the anesthetists, physicians who provide anesthesia and vital monitoring, refused to participate in any high complexity cases. [11] Following the death of the twelfth child in under a year, the head of the ICU refused to refer any more patients to the surgeon’s team and the program was halted.

The inquest, led by Judge Murray Sinclair, was lengthy and thorough in scope. It raised serious issues about the amount of organizational support and culture within the institution. Judge Sinclair noted that the institutional culture was such that nurses were not empowered to report problems. Notably, significant deficits in transparency both within the program and to parents existed. Sinclair said of the situation, “…I hesitate to say conspiracy of silence, but a lot of things were happening in the operating room which was not shared with parents until the inquest began.” [14]

The inquest led to the regionalization of cardiac surgical services through the creation of the Western Canadian Children’s Heart Network. [15] Regionalization means the reduction of centers in an area to ensure a proper number of cases to maintain skill and experience. The more complicated surgeries were all done in one central place, to ensure quality and safety, more volume is thought to equate to better outcomes. This network was established to “…improve interprovincial cooperation and partnership.” [8] WCCHN took Sinclair’s main recommendations to heart. WCCHN focuses on the values of collaboration, quality, collegiality, respect, transparency, and engagement. [15] The program at Winnipeg never re-opened. Children seen in Winnipeg requiring heart surgery are referred to other facilities within the province.

Bristol Royal Infirmary

Around the same time problems were noted in Winnipeg, a cardiac surgery program in Bristol, England faced a media scandal. Between 1991-1995, mortality at Bristol was double that of other centers. [16] Around thirty children are said to have been affected.

An inquest similar to the one in Winnipeg was ordered. As in Winnipeg, the inquest found that the voices of professionals who raised concerns were initially ignored until the problems became too egregious to hide. At that point it was leaked to the media and citizens began to protest. The inquest highlighted the unbalanced power dynamics of the program, the low volumes of patients, and what they called “cultural and structural issues.” [17] Bristol, they said, had problems stemming from a “club culture” and “professional hubris.” [16,17] After the inquest, the program closed permanently.

Kentucky

In 2013, Kentucky Children’s Hospital in Lexington, KY experienced higher than expected mortality rates, at least four children died that might not have elsewhere. [18] The hospital did not make these rates public. They didn’t share their data and outcomes with families because a hospital executive said it would be too complicated. [18] When journalists inquired, the hospital sought legal protection to keep records secret, citing patient privacy. The journalists fought the hospital in court and won. When the data came out it showed their mortality rates higher than the national average. [18] One parent reports that after months of complications with their child a cardiologist pulled her aside said, “If I were you, I would move him.” [18] They transferred to another hospital where their child was found to be in heart failure. After five children died the program was suspended and has since restarted in partnership with Cincinnati Children’s Hospital Medical Center.

St. Mary’s

Scandal rocked St. Mary’s hospital in West Palm Beach not long after the hospital opened its cardiac surgery program in December 2011. By 2013, cardiologists from the south Florida area noticed an unusually large number of complications from pediatric cardiac surgeries done at St. Mary’s. [19] They requested that the program be audited, yet the hospital did not request an audit. The cardiologists reached out to a well-known outside expert in pediatric cardiology. After reviewing the program, he wrote a seven-page letter outlining his concerns. This did not prompt any action. [20] Parents report odd encounters at the bedside. The parents of a child who finally transferred out of St. Mary’s and was found to be paralyzed after surgery recounts the surgeon and cardiologist arguing at the bedside over whether their child was in severe pain after waking up from surgery and to give the child opioid analgesics for pain. They recount that their child had high blood pressure, seemed uncomfortable, and seemed to not move her legs. The parents demanded transfer; the surgeon attempted to talk them out of it. Their child is paralyzed from the waist down.

Only after six children died did things change. The state of Florida investigated. Dr. Jeffrey Jacobs, head of the state investigation at St. Mary’s found that the hospital was doing too few surgical procedures to “acquire and maintain proficiency” in complex surgeries and that the situation “is not the failure of any one individual. It is a failure of the entire team and system.” [21] In June 2014 Dr. Jacobs recommended that St. Mary’s stop doing cardiac surgery on children and particularly in children under six months of age. [21] The hospital initially made no changes but following significant media scrutiny, the hospital closed its pediatric cardiac surgery program in August 2015. They did so only grudgingly, citing “inaccurate media reports” that “made it significantly more challenging to build sustainable volume in our program.” [21] Investigative journalists had calculated St. Mary’s mortality rate during this period at three times the national average. [21] Here too, clinicians were reaching out for accountability, warning of problems. They even received expert analysis and advice, yet nothing was done until information was given to the media.

University of North Carolina

In 2016, pediatric cardiologists at the University of North Carolina noticed that their hospital’s rates of serious complications after cardiac surgery, including mortality, were nearly twice the national average, and had been so since 2013. [22] They expressed concerns to the hospital’s administration. They made specific recommendations to improve the quality of care, including hiring more intensive care unit (ICU) nurses and building a dedicated cardiac ICU. They questioned whether some of the ICU physicians and heart surgeons had the necessary skills needed to provide the highly specialized and coordinated care. The hospital administration initially dismissed these concerns. The cardiologists were so concerned with the poor outcomes that they began referring their surgical cases elsewhere.

Care of children with heart disease requires seamless cooperation between cardiologists, cardiac surgeons, and many other professionals to develop a cohesive highly functioning team. Cardiologists perform the initial diagnostic evaluation and if needed, refer patients to cardiac surgeons. Surgery is complex and requires a large multidisciplinary team before, during, and after surgery. The fact that UNC’s cardiologists did not trust their institution’s program showed how badly their team was functioning. This should have triggered a serious review of the quality and safety of the program. Instead, the cardiologists who reported problems were treated as if they, themselves, were the problem. Instead of devising remedies, hospital leaders threatened to fire the cardiologists. The Chair of Pediatrics, Dr. Kevin Kelly, said, “If [referring patients elsewhere] reduces the volume of things, I’ll just – we’ll just reduce the number of people that we have.” [22,23]

The cardiologists were so concerned with the bad outcomes and the lack of institutional remedies that they decided to become whistleblowers. They recorded conversations with administrators and gave those recordings to The New York Times, which published a detailed and scathing exposé in 2019. [22] Following the public exposure, Lisa Schiller, a spokeswoman for UNC, said of the complaints, “They were handled appropriately, and today we have new team members.” [24] UNC cited leadership changes including the appointment of a new chief surgeon last year.

The problems at UNC came to light because of the cardiologists’ whistleblowing. Administration was not only aware of the issues but told The New York Times their own internal investigation of the pediatric cardiac surgery program determined the “criticism of the program was found to be unsubstantiated.” Hospital leaders attributed any perceived problems to “a dysfunctional group” in 2016 that sowed mistrust, creating “team culture issues.” [22]

We don’t know how many programs have similar problems that have not come to light. We rely on the integrity of the doctors and hospital leaders to investigate, analyze, and report their performance. UNC was not an isolated incident. Similar things have happened before and since.

All Children’s

All Children’s Hospital in St. Petersburg, Florida, an affiliate of Johns Hopkins, had an established pediatric cardiac surgery program. In 2016, doctors and nurses began to notice avoidable complications, including sharp increases in infection rates, sepsis, wound dehiscence, need for life support, and mortality rates. [25,26] Needles were left in the hearts of two different children following cardiac surgeries and the errors were not disclosed to parents. [25] Physician assistants who worked in the operating room voiced concerns to senior hospital leadership. They were ignored. A cardiologist wanted to compare the hospital’s outcomes with national averages. Hospital administration denied her access to the hospital’s outcome data. Later, in sworn testimony, she said, “Multiple levels of administration had actually tried to hide some outcomes.” [27] Doctors and physicians’ assistants who tried to improve care were demoted. Some left the institution and sought work elsewhere.

Instead of critically examining the hospital’s troublesome outcomes, the senior administrators covered them up. The program continued to grow. Outcomes did not improve. In 2018, based on tip-offs from parents and doctors, the Tampa Bay Times used legal pressure to get access to hospital outcomes statistics. They published a detailed exposé of the many problems at All Children’s that makes frightening reading. [27] Eleven children died and several suffered serious complications. The hospital has paid out over 40 million dollars in damages. [28]

Only after this exposé was published did hospital administrators seriously examine what was going on and make changes. Investigators reported several structural issues around culture, monitoring, and accountability. All Children’s now faces record fines and was even in danger of losing federal funding—a rare occurrence. The program was halted, senior leaders and clinicians were forced to resign, including a surgeon who had lectured about cardiac surgery outcomes and the scandals of Bristol and Winnipeg. [29] Again, as at UNC, Winnipeg, and Bristol, warnings were made, there was no accountability either through inattention or deliberate denial.

Cardiac Surgery Scandals: Analysis of Causes

This analysis should not be viewed as an attack on pediatric cardiac surgery or any particular discipline. Our analysis rejects the idea that these issues are the result of sole bad actors; these were system failures. Pediatric cardiac surgery is an amazing field and has saved countless children from what would be certain death. Not all cardiac surgeries will go well; some children will suffer morbidities, some will even die. Not every death after surgery is the result of inexperience, error, or negligence. While data is complicated to interpret, overall national mortality for cardiac surgery is low, particularly in light of the grave condition of the patients needing surgery to begin with.

Deaths in one center can alter the perception of the program in ways that might look dire, but a deeper inspection of the context may reveal disease complexity rather than systemic problems. However, how a program responds to changes in outcomes or concerns of frontline providers is a different matter.

The two seminal investigations into these scandals, the Manitoba and Bristol inquests, noted some concern around volume to maintain outcomes but focused the majority of their analysis on communication and power dynamics between team members, particularly surgeons and other members, administrative/organizational transparency and accountability, and promoting the programs over patient safety. While volume certainly has been correlated with outcomes, given the number of low volume cardiac surgery programs,  a correlation between volume and scandals would suggest many more scandals than have occurred.

The themes identified by the inquests at Manitoba and Bristol, and the data from the other scandals, suggest that while low volumes might have been a factor, what led to the scandals was the lack of transparency, accountability, unbalanced power dynamics, and a focus program ‘success’ over patient outcomes. Similar themes were found when the Bristol case was analyzed by an expert in pediatric cardiac surgery. [30] These themes were present in every U.S. program in which a scandal occurred, and had they not been, the worsening outcomes may have been noticed, clinicians’ concerns taken seriously, and less harm done to children.

There are two factors behind the themes described above: profit and prestige. We will discuss these two factors and then discuss how regionalization of pediatric cardiac surgery programs would address these issues. We will then discuss some of the barriers to regionalization and why that approach does not adequately address the themes which seem to underlie the scandals.

Pediatric cardiac surgery programs have been said to be the revenue engines of children’s hospitals and support “…underfunded programs within children’s hospitals that are necessary to care for sick children.” [311690] This is hard to prove, though it has been stated by many prominent experts in the field. [31,32] These statements in the literature contain no source information or data for these claims; they are anecdotal, but the belief is ubiquitous within pediatric hospital clinicians.

Tracking revenue from specific hospital programs is not as simple as one would like. When administrators were asked by the authors of this paper about the support of underfunded programs by the revenue from cardiac surgery programs statement, most agreed but could not produce data to prove it. The closest data that exists is the operating revenue loss from Johns Hopkins Health System, whose own financial report contributes to the “…decrease in income from operations and operating margin percentage was mainly driven by lower net patient service revenue at [All Children’s] as a result of the closing of the Heart Institute.” [3316] The entire health system’s operating profit fell 70%, with an $11.5 million profit loss from All Children’s alone. [28,33] Operational income for the first three months of 2019 declined by $31.7 million compared to the same three months of 2018 (operating margin percentage fell from 2.7% to 0.8% for this same respective comparison period). [3316] The financial report states that this “…decrease in income from operations and operating margin percentage was mainly driven by lower net patient service revenue at JHACH [All Children’s] as a result of the closing of the Heart Institute…” [3316] If the total decline of $31.7 million is due to All Children’s Heart Institute closing, then it was generating a fairly large amount of revenue for the children’s hospital and also the Johns Hopkins Health System overall, about $10.5 million per month.

Psychologically, children’s hospitals benefit from the status these programs provide, as well as from the diffusion of experience beneficial to other specialty programs. For most children’s hospitals it is impossible to be considered a “top-tier” center without a pediatric cardiac surgery program, as it is attached to several other services. Many center verifications for surgery and neonatal care rely on the services of cardiac bypass that cardiac programs help ensure. If you want to be a verified top-level surgery center you need to have a top-level neonatal ICU. If you want a top-level neonatal ICU, you need a cardiac bypass program. To maintain the skill of staff in bypass you almost certainly need a cardiac program.

It is psychologically and economically tempting to cut corners. By one view these programs might be enticing from a revenue standpoint. And indeed they are likely revenue engines in the U.S. They also support many other programs through ensuring clinician skill levels. They provide prestige through the amazing successes they produce. But an important question that has not been answered is whether they are as economically productive as we think. Certainly the revenue might be robust, but as of yet we have little data on the startup and overhead costs of such programs. As we have discussed, these programs require considerable support and attention, a large and diverse team, continual education and training, and technologically sophisticated resources. One wonders whether inadequate attention to the importance of these factors may have contributed to poor outcomes followed by the lack of transparency and accountability to intervene. Regionalization of these programs in a hub and spoke model, limiting the number of centers, seems to be an adequate way to respond.

Regionalization as a Solution

The solution to low volumes—and the resultant risk of low quality—is, in theory, simple and straightforward. Such surgery should be done in only a relatively few centers. Regionalization would group resources and experience in less centers and based on the volume/outcome relationship, this would improve outcomes via mortality data. The UK’s National Health Service (NHS) came out with regionalization recommendations after the Bristol scandal. The NHS studied the resources needed and the minimum volume of surgery necessary for programs to be “safe and sustainable.” [34] The report proposed standards that would require cardiac surgery units to have minimum four surgeons, 24-hour coverage and a minimum of 400 pediatric cases per year. [34,35] This was only partially achieved because Bristol closed following the scandal. This closing lowered the number of pediatric cardiac surgery centers in the UK to eleven. By the NHS recommendations, the UK still needs to reduce to six or seven. [35] As of this writing, the UK has not adopted the “safe and sustainable” recommendations.

Theoretical regionalization has been studied and shown to reduce mortality. [36] Though theoretically sound, the data on regionalization itself is sparse and incomplete. The Swedish study, Lündstrom et al. [9] found improved mortality rates when the country “centralized” their pediatric cardiac surgery centers. While the mortality rate did drop about 8%, it was unusually high to begin with. Prior to the reduction it was upwards of 9% and dropped to about 1.7%. [9] The U.S. mortality rate is around 3.5%. [32] Slovakia and Slovenia also had far fewer programs, and partnered between countries with help from Boston Children’s. [10] Meaningful mortality data from their venture was not measurable at time of publication. [10] Additional research has also shown the burden on families in travel is low, a common argument against regionalization. [32] More studies are in the works but there is a major barrier in the U.S. to regionalization that has not been addressed.

In 2015, a meeting of experts in pediatric cardiac surgery examined the prospects for “regionalization” of care in the U.S., pointing to the scandals as motivating reason. [36] Currently, about 125 hospitals in the U.S. have a pediatric cardiac surgery program. [37] If we assume that there are 40,000 CHD surgeries/year, with 10,000 of those being a critical CHD, then that would entail roughly 320 total surgeries, of which 80 are critical CHD surgeries, in each center per year assuming center volume was evenly apportioned. This is below the minimum deemed necessary by the UK’s NHS report and EACTS recommendations. By the NHS and EACTS calculations, instead of 125 programs, the US would need, at most, only 65 pediatric cardiac surgery centers. [32,37] To achieve that number, half of the programs in the U.S. would have to close or merge.

To achieve regionalization hospitals would have to work together and/or work with the state or federal government—something hospitals have little incentive to do. State regulation could help but is unlikely to occur and past attempts by states to have hospitals justify the needs for new programs have largely been unsuccessful. Even if states did pursue regulation many “regions” transcend state borders. Any realistic regionalization plan would require states to work together or seek federal involvement. The only other feasible strategy would require one hospital system to control a particular region or a national or regional health service, something not historically embraced in the U.S. Regionalization of pediatric cardiac surgery programs is unlikely to be accomplished in the U.S. without addressing the fiscal and psychological incentives it provides.

While we often dismiss comparisons of U.S. healthcare with systems in Canada and the UK—except when we look to their outcome data on “regionalization”—many similar pressures are present, even if more hidden. Prestige and financial incentives are still present even in a socialized system. Socialized healthcare still relies on budgets and foundations. Pediatric cardiac surgery is a driver of prestige and fundraising, which could motivate a desire for more complex surgeries without proper experience and preparation. While the systems are different, the themes between the US scandals and Bristol and Winnipeg were the same. They even called for regionalization in those countries in response to the scandals, and only Manitoba has achieved it.

While regionalization has been the solution put forward by the industry to address the problems from recent scandals it only addresses the issue of volume. It is possible to have low volumes and good outcomes. In fact, looking at the Society for Thoracic Surgery (STS) [38,39] public reporting database prior to recent changes in how they rate programs found a host of lower volume programs with better ratings and mortality than higher volume programs. Penn State Children’s had the highest rating of three stars and an observed operative mortality rate of 1.1% with a four-year volume of 560 patients. Boston Children’s had a two-star rating, 2.4% observed operative mortality rate, and four-year volume of 3,290. [39] STS has since removed the star ratings from its listings, but the mortality rates speak for themselves. There is certainly much nuance to these data.

One reason why volume and outcomes are not straightforwardly correlated is that the highest volume programs may also take the most complex cases. Thus, their mortality rates may be higher not because they are providing lower quality care but because they are willing to try to save the sickest and most complex patients. There are other factors that may be present at high volume centers such as a higher availability of well-equipped operating rooms, more resources, design and deployment of new technologies, a comprehensive care team with multidisciplinary discussions, standardized management protocols, and improved resilience and recognition and treatment of complications. [40] The role of human factors such as team training, communication, debriefing, team culture and dynamics are also not well captured by the current methods of measuring outcomes. [40] These human factors are where we see the main themes present in these scandals, essentially the lack of attention to the institutional and program climate.

We have outlined the financial and psychological pressures children’s hospitals have in having and maintaining cardiac surgery programs. These pressures can influence administrative leaders to value the growth of the program over the quality of the patient outcomes. This, in turn, may lead to inadequate monitoring of quality and safety and the silencing of voices that are trying to point out real problems. When this happens, clinicians are faced with difficult ethical tensions.

Frontline caregivers who work in a dysfunctional and toxic culture face the tough choice of whether to ignore the problem, leave the institution, or, when there are perceived to be egregious but ignored ethical issues, become a whistleblower. Becoming a whistleblower takes courage. It requires a high level of frustration and a willingness to put one’s career and that of their colleagues at risk. Leaving the institution is also risky. Sometimes, the easiest option for staff is to compromise their own values and be loyal to the institution.

Being a whistleblower is both courageous and commendable, but the need for a whistleblower signals that there have been failures in the mechanisms that should be present to promote transparency and quality assurance. Asking individual clinicians to be morally courageous as a way to address dysfunctional system structures and conditions is a deflection of administrative responsibility. [41] Frontline caregivers do not aspire to be whistleblowers. They would much prefer to have their concerns taken seriously and the problems that they identify addressed. They become whistleblowers only when they witness events that cause frustration and they are unable to make change through proper channels. Whistleblowing becomes the only path to satisfy their ethical commitments—which have been long since violated by the time they speak out.

In each of these scandals, leaders disregarded warnings from front-line caregivers. When institutions fail to ensure the conditions for a culture where stakeholders have equal voice, the ship starts to sink. The first ones to sound the alarm may be the people in lower decks. Their voices are often disregarded. These “first responders” may not know how bad things really are. They may notice problems before things get really bad. If their concerns lead to corrective action, then things may never get worse. If not, things progress until enough death or disability happens to prompt scandal. By then the ship has sunk.

Across the scandals reviewed, there was a complete lack of accountability over both administrative and clinical leaders. This ensures that these problems will only be addressed by a more devastating outcome, leak to the press, or constant staff turnover finally becomes too much for the organization to bear. These are preventable situations. Regionalization has strong theoretical promise even without strong data. It is likely an overall good for all patients requiring specialized programs. However, it is not likely to happen in the U.S. and even if it did, it does not address the root causal factors that led to the scandals in these programs. We will next discuss our hypothesis built on the analysis of these scandals: that attention to a healthy ethical climate can identify problems from low volumes and provide a more upstream approach to ensure appropriate conditions are present to prevent these types of ethical issues.

Ethical Climate as Preventative Ethics

We hypothesize that bad outcomes often provide a catalyst—something tangible that allows whistleblowers with more power to finally speak out—as good outcomes in a bad culture likely tamps down dissenting voices. It might be the whistleblowers knew about the bad culture the whole time, but only felt compelled to act when a patient suffered a severe harm and the ethical tension become too much to bear. This might speak to organizational culture, unit culture, and interdisciplinary team dynamics. Those problems could be identified and addressed if the culture were to encourage transparency, accountability, and a flattened hierarchy that validates and encourages cohesive and collaborative teams; preventative ethics through ensuring the conditions required for an ethical climate.

There is an ethical obligation to build and maintain the conditions that foster constructive cultures in these programs. The conditions that must be built in are a commitment to patients over program, monitoring and accountability, and an empowered team-based culture that allows for and promotes communication. Dr. Martin Elliott summarizes these ethical obligations and expectations in a lecture about the Bristol case:

…[parents] would expect to be confident in the knowledge that you are heading for a place that is expert, which is specialized and in which work people who are there because they are highly trained and good at their job, who work in high quality teams, whom you can trust and whom you can believe. People who work in appropriate conditions and have access to everything they need if things go wrong. [42]

Motivated by the Institute of Medicine’s “To Err Is Human” report released in 2001, there has been a push towards “safety culture.” [43,44,45] There is also a wealth of literature demonstrating the association between nurse work environments and patient safety outcomes. [44,46]

Johns Hopkins began a program focused on team cohesion, quality and safety in ICUs and with surgical patients. [43,47] This “trust-based accountability model” employs a systems approach creating multidisciplinary teams with leadership support and involvement that harnesses the “…intrinsic motivations of clinicians…” to improve patient outcomes and avoid preventable harms. [43676]

Another example of improving care and avoiding preventable harms in healthcare is the CREW resource management (CRM) method originally developed for the airline industry. [48,49] CRM provides a strategy to reduce human error by optimizing teamwork and communication in complex and high-stakes environments. 48 The antecedents to these different strategies is found in the underlying foundation of an ethical climate.

Recommendations for Cardiac Surgery Programs

We recommend that these programs be established with the tenets of an ethical climate embedded in their infrastructure. The essential domains of an ethical climate specific to pediatric critical care identified by Moynihan et al. (2021) [50] are:

  1. Organizational culture and leadership
    • Executive and department level leadership must be tangibly committed to fostering open and respectful communication. Staff empowerment to speak up is supported by an environment that promotes questioning and learning particularly in discussing and responding to ethical issues. Transparency in data, outcomes, and how it is analyzed and used in performance improvement is necessary.
  2. Interdisciplinary team relationships and dynamics
    • Investment in building and maintaining high-quality collaborative teams with a flattened hierarchy; staff must feel empowered to be a vocal part of the team as a partner.
  3. Integrated child and family-centered care
    • Families need to be integrated into the team as a partner, with recognition that a dynamic and multidisciplinary team with families inherently includes cofiduciary obligations and that multiple ‘right’ courses of action might exist. Discussion between the team and family must be transparent with understanding of different perspectives and responsibilities.
  4. Ethics literacy
    • Individual level of ethical awareness and institutional and departmental commitment to supporting education and space for learning and discussion of ethical issues. Increasing individual clinician abilities to critically reason, recognize the difference between fact and value claims, identify bias and assumptions, and understand complex ethical concepts improves interdisciplinary team dynamics and empowers members to speak up in constructive ways. Leaders must support and invest in infrastructure to support this. Ethics literacy is linked with the domain of organizational culture and leadership.

While we don’t know the level of ethics literacy of the staff in these cases, the other ethical climate domains were clearly either not present or not functioning in the centers that had scandals. This led to only one recourse for staff to voice their concerns—becoming a whistleblower. Thankfully they did, but relying on the moral courage of staff to overcome institutional obstacles is a serious ethical oversight by leadership. [40]

Hospitals must rely on the integrity of front-line professionals to review their own data, identify problems, and seek remedies. An increase in bad outcomes, whether connected or coincidental, should be scrutinized. This requires resources in personnel and time. It requires honesty not only with patients and communities, but a commitment to maintaining a team that has equal ability to discuss concerns. This may necessitate halting of scheduled procedures. Financial responsibilities and pressures absolutely cannot override ethical commitments to patients, families, and staff.

All voices must be heard and acknowledged because everyone has to work toward a common goal. The basic theory behind many of these strategies is one of organizational commitment to an ethical climate. A culture of safety in healthcare should be synonymous with an ethical climate.

Program data need to be shared widely among both the hospital staff and the public. That data can then be critically and contextually examined. Leaders who hide data from their own staff create the kind of “club culture” found at Bristol. Working in such a culture, staff lose confidence in the institution’s ability to provide their best care.

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Conclusion

As we have argued, there is a set of organizational themes consistent across theses scandals: a lack of transparency, accountability, unbalanced power dynamics, and a focus program ‘success’ over patient outcomes. The lack of a full inquests in the U.S. only contributes to the problem of the lack of transparency. The fact that these issues have not arisen in other countries that we know of probably speaks to the institutional support for these programs to ensure quality where there is less financial competition or hierarchical silence. Of course, prestige is always present in any program, socialized or not, and constructive when checks are in place. Bad ethical climates can exist anywhere.

Regionalization alone is not the cure. The themes found in this paper show the ethical imperative is to ensure an ethical climate: healthy organizational culture and leadership, interdisciplinary team dynamics, integrated child and family-centered care, and ethical literacy.

This is human work and we cannot forget the need to attend to these human elements. These cases highlight the importance of building ethics within a system, the conditions of which are structurally built from the ground up—not applied at the end or ad hoc. Structure drives behavior, and these scandals should be regarded as examples of the disastrous consequences when structural factors constrain ethical practice.

As Sir Ian Kennedy noted in the report on Bristol hospital:

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These stories are not of bad people who did not care or who willfully harmed patients. These are stories of people who cared greatly about human suffering, were dedicated and well motivated. But some lacked insight, had flawed behavior, communicated badly and failed to work together, in the interests of the patient (Kennedy 2001). [10]

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Limitations and Future Directions

We are limited in what we know from the U.S. cases, which does make this analysis somewhat speculative. However, the main themes were consistently present alongside each scandal, and were the same problems found in Bristol and Winnipeg (and are not wholly unknown in healthcare generally).

It is also noticeable that where patients that were harmed were identified, the majority were from Black, Indigenous, and Latinx communities [12,22,27] and should be researched further.

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The authors have disclosed no conflicts of interest.

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Affiliations

Ian D. Wolfe, Ph.D., RN, CCRN, HEC-C
Children’s Minnesota Clinical Ethics Department

John D. Lantos, MD
Children’s Mercy Bioethics Center
Kansas City, Missouri

Correspondence

Ian Wolfe
Children’s Minnesota Hospital
Clinical Ethics Department
2525 Chicago Ave S, Mailstop 17-750
MPLS MN 55404.
612-839-5863
wolfe370@umn.edu

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