PART 4. New Jersey. “..heart transplant center, inflated survival rates to keep its funding — keeping a brain-dead patient on life support until he hit a one-year survival benchmark..”

When I started as President & CEO of Jersey City Medical Center in 1989, New Jersey had a comprehensive Certificate of Need process. When the state awarded a “CN” funding followed through the all payor reimbursement system then in place.

Over time JCMC was designated as: a Regional Perinatal Center; Level II Trauma Center; Teaching Hospital Cancer Program; a Children’s Hospital; and approved to start cardiac surgery/ interventional cardiology. With these programs JCMC became a major teaching affiliate of Mount Sinai School of Medicine and a total replacement hospital was opened on a new site in 2004.

The pediatric cardiac surgery problems at Johns Hopkins All Children’s Hospital and North Carolina Children’s Hospital are due, in part, to the disappearance of most state CON regulations resulting in hospitals opening “trophy” services that lead to low volume programs. Funding becomes a challenge.

ASSIGNMENT: What are the Lessons Learned from the Johns Hopkins All Children’s Hospital and North Carolina Children’s Hospital pediatric open cardiac surgery program failures? What are the regulatory implications?

Please contact me a jonathanmetsch@gmail.com if you would like to discuss preparation for this case.

After New PART 4 are excerpts from Parts 1-3, as well as an unabridged chronology.

PART 4. Johns Hopkins All Children’s Hospital and North Carolina Children’s Hospital pediatric cardiac surgery programs at “crossroads.”

“The hospital that calls itself New Jersey’s premier heart transplant center, Newark Beth Israel, inflated survival rates to keep its funding — in at least one instance by keeping a brain-dead patient on life support until he hit a one-year survival benchmark, startling new reporting revealed.

Family members were never told that Navy veteran Darryl Young was in an irreversible vegetative state after his heart transplant last year, and staff never offered hospice, other palliative care services or a Do Not Resuscitate directive, ProPublica revealed.

Meanwhile, behind the scenes, doctors were secretly recorded discussing how Young needed to be aggressively cared for despite their belief that he would never wake up or recover function, the ProPublica report said.” (H)

 “The North Carolina Children’s Hospital got a bit of good news last week from a state agency that sent a team of investigators on-site for 11 days of questioning and review of the pediatric heart surgery program.

The state Department of Health and Human Services says the program currently is in compliance with U.S. Centers for Medicare and Medicaid Services requirements…

An external review board was tapped to evaluate the program and new Quality and Safety reporting procedures were put in place.

The external review board has had one telephone conference meeting, according to Alan Wolf, a spokesman for the health care system, and has plans to meet in person soon.

Despite the state health department’s findings, the UNC Health Care system has no plans to schedule those types of surgeries before the external review is complete, according to Wolf.” (A)

“The families of two children who were paralyzed after heart surgeries at Johns Hopkins All Children’s Hospital will receive $26 million and $12.75 million in settlements with the hospital, state records show.

Although the identities of the children are not public, the records describing their cases match two of the patients featured in a Tampa Bay Times investigation into the hospital’s troubled heart unit. Both families were struggling with the costs of caring for a permanently disabled child with no relief in sight.

A third family that lost a child after heart surgery will receive $750,000…

In June, Johns Hopkins Health System CEO Kevin Sowers told the Times that he and hospital leaders had reached out to the families of children who died or were injured in the hospital’s heart surgery unit.

“We made a mistake, and we need to make sure we help support these families and make it right,” he said…  (B)

“UNC Hospitals in Chapel Hill is on probation after the system received preliminary denial of its accreditation.

Preliminary Denial of Accreditation is recommended when there’s an immediate threat to health and safety, a submission of falsified documents or misrepresented information, a lack of a required license, or significant noncompliance with Joint Commission standards, according to the Joint Commission..

“To be clear: There was no finding of any immediate threats to patient health and safety,” UNC Health Care spokesman Alan Wolf said in an email.

The Joint Commission recently conducted the triennial accreditation survey, when surveyors examined the main hospital in Chapel Hill.

UNC Health Care credited the slide in accreditation to new standards by the Joint Commission. The hospital will remain on preliminary denial of accreditation status until the hospital undergoes a new survey and satisfies the requirements.

The hospital network says it has already put plans in place to fix each problematic area…

UNC Health Care said the Joint Commission accepted its plans of correction, and expects the validation survey to take place next week.” (C)

UNC Hospitals is one step closer to regaining its clean reputation, but concerns remain.

After completing follow-up inspections, the Joint Commission lifted its preliminary denial of UNC Hospitals’ accreditation and upgraded the hospital to “accreditation with a follow-up survey.”

UNC Hospitals was originally placed on probation because it failed to meet the suicide prevention standards of the Joint Commission…

Most of the serious problems revolved around the treatment of mental health patients, particularly those at risk for suicide attempts or for being abused and exploited. The Joint Commission demanded better management of ligature risks — places where a patient could hang or choke themselves — and better identification of potential victims of abuse.

The Joint Commission only recommends Preliminary Denial of Accreditation when there’s an immediate threat to health and safety, a submission of falsified documents or misrepresented information, a lack of a required license, or significant noncompliance with Joint Commission standards…

The clean bill of accreditation means the Joint Commission is satisfied with UNC Hospitals’ response to its performance issues. But the hospitals will probably face added scrutiny.”  (D)

A North Carolina children’s hospital that stopped performing complex heart surgeries in recent months after high death rates were disclosed may now resume the procedures, according to an advisory board that was examining the hospital’s practices.

The board noted “significant investment and progress” had been made at North Carolina Children’s Hospital while suggesting areas for improvement, including increasing the number of surgeries performed, a factor associated with better outcomes.

The external board made its recommendations in a six-page report released on Tuesday by UNC Health Care, which runs the hospital and is affiliated with the University of North Carolina…..

The advisory board did not seem to address conditions at the hospital when doctors voiced concerns several years ago, but noted that “team dynamics and interactions appear to be strong.” Recommendations it made to the hospital’s board of directors included continuing to publicly report mortality data; hiring a second full-time pediatric heart surgeon; and considering a joint venture with another hospital to increase the volume of surgeries.

Concerns about the quality of pediatric heart surgery programs have been disclosed at hospitals across the country, especially at institutions with a smaller number of surgeries. Several programs have been suspended or shut down; other hospitals have merged their programs with larger ones to achieve more consistent results.

The advisory board was composed of three doctors from outside institutions: Nationwide Children’s Hospital in Columbus, Ohio; the University of Michigan School of Medicine; and Children’s Hospital of Pittsburgh.

Two doctors leading UNC’s pediatric heart program previously worked at two of those institutions: Dr. Timothy Hoffman, chief of pediatric cardiology, came to UNC from Nationwide Children’s Hospital. Dr. Mahesh Sharma, chief pediatric cardiac surgeon, joined UNC from Children’s Hospital of Pittsburgh.” (E)

“The News & Observer reports the outside review board’s report was announced Tuesday. It noted ongoing improvements in the unit, though it advised the hospital to consider if patients with complex heart problems along with additional illnesses should be referred to other hospitals.” (F)

“Rumors floated around a children’s heart surgery unit in a major hospital of a major city. Babies operated on for complex heart problems were dying, and dying at rates far higher than those of comparable hospitals. Doctors and cardiologists feared, even avoided, referring young babies for surgery at the unit — a culture of silence surrounding it all…

But this is not UNC. And this is not 2019. This was thirty years ago at Bristol Royal Infirmary, the flagship hospital of Bristol, a city of about 500,000, in the United Kingdom.

“It would be reassuring to believe that it could not happen again,” wrote Sir Ian Kennedy, chair of the public inquiry into the tragedy that claimed the lives of dozens of babies at Bristol. But he didn’t sound particularly reassured, and sadly his doubt has been borne out. It has happened again.

The parallels between the two scandals are uncanny. At both hospitals, the cardiac surgery for very young babies was malfunctioning, and babies were dying at appalling rates. At both hospitals a culture of silence surrounded a growing sense among staff that something was going catastrophically wrong.

And at both hospitals it took outsiders to blow the whistle: at UNC someone leaked recordings of the conversations held by a group of concerned cardiologists (doctors who refer patients to cardiac surgery) in June 2016 to the New York Times. Dr Kevin Kelly, leader of the children’s hospital at UNC, had convened the meeting to discuss the “crisis.” “When you walk out of here,” he says in the recordings, “stop talking about it outside of this room.”

At Bristol thirty years ago, a young new anesthetist named Stephen Bolsin grew concerned about eight-hour operations instead taking twelve. He began to collect data on the outcomes of babies at the unit. When he sensed the numbers didn’t look good, he took his concerns to the head of the unit, surgeon James Wisheart, who shut him down.

When Bolsin went over his head to the hospital manager, Wisheart got wind of this breach in the strict medical hierarchy and said this amazing – and terrifyingly similar – thing: “If you wish to remain in Bristol you should not disclose the results of pediatric cardiac surgery to people outside the unit ever again.”” (G)

PART 1. Brand names don’t always signify the highest quality of care

 “Sandra Vázquez paced the heart unit at Johns Hopkins All Children’s Hospital.

Her 5-month-old son, Sebastián Vixtha, lay unconscious in his hospital crib, breathing faintly through a tube. Two surgeries to fix his heart had failed, even the one that was supposed to be straightforward.

Vázquez saw another mom in the room next door crying. Her baby was also in bad shape.

Down the hall, 4-month-old Leslie Lugo had developed a serious infection in the surgical incision that snaked down her chest. Her parents argued with the doctors. They didn’t believe the hospital room had been kept sterile.

By the end of the week, all three babies would die…

The internationally renowned Johns Hopkins had taken over the St. Petersburg All Children’s Hospital six years earlier and vowed to transform its pediatric heart surgery unit into one of the nation’s best.

Instead, the program got worse and worse until children were dying at a stunning rate, a Tampa Bay Times investigation has found.

Nearly one in 10 patients died last year. The mortality rate, suddenly the highest in Florida, had tripled since 2015…

Times reporters spent a year examining the All Children’s Heart Institute – a small, but important division of the larger hospital devoted to caring for children born with heart defects…

They discovered a program beset with problems that were whispered about in heart surgery circles but hidden from the public.

Among the findings:

All Children’s surgeons made serious mistakes, and their procedures went wrong in unusual ways. They lost needles in at least two infants’ chests. Sutures burst. Infections mounted. Patches designed to cover holes in tiny hearts failed.

Johns Hopkins’ handpicked administrators disregarded safety concerns the program’s staff had raised as early as 2015. It wasn’t until early 2017 that All Children’s stopped performing the most complex procedures. And it wasn’t until late that year that it pulled one of its main surgeons from the operating room.

Even after the hospital stopped the most complex procedures, children continued to suffer. A doctor told Cash Beni-King’s parents his operation would be easy. His mother and father imagined him growing up, playing football. Instead multiple surgeries failed, and he died.

In just a year and a half, at least 11 patients died after operations by the hospital’s two principal heart surgeons. The 2017 death rate was the highest any Florida pediatric heart program had seen in the last decade.

Parents were kept in the dark about the institute’s troubles, including some that affected their children’s care. Leslie Lugo’s family didn’t know she caught pneumonia in the hospital until they read her autopsy report. The parents of another child didn’t learn a surgical needle was left inside their baby until after she was sent home.

The Times presented its findings to hospital leaders in a series of memos early this month. They declined interview requests and did not make the institute’s doctors available to comment.

In a statement, All Children’s did not dispute the Times’ reporting. The hospital said it halted all pediatric heart surgeries in October and is conducting a review of the program.

“Johns Hopkins All Children’s Hospital is defined by our commitment to patient safety and providing the highest quality care possible to the children and families we serve,” the hospital wrote. “An important part of that commitment is a willingness to learn.” (G)

The top three leaders of Johns Hopkins All Children’s Hospital in Florida resigned Tuesday following a Tampa Bay Times investigation that revealed increasing mortality rates among heart surgery patients.

The resignations from the 259-bed teaching hospital in St. Petersburg included CEO Jonathan Ellen, M.D., and Vice President Jackie Crain, as well as Jeffrey Jacobs, M.D., who is the heart institute’s deputy director, the Tampa Bay Times reported. Paul Colombani, M.D., stepped down as chairman of the department of surgery but will continue working in a clinical capacity, a statement from the health system said…

Johns Hopkins, which owns and operates the hospital, said it would install Kevin Sowers, who is president of the Johns Hopkins Health System and executive vice president of Johns Hopkins Medicine, to lead the hospital in a temporary capacity while a plan for interim leadership is put into place.

Johns Hopkins’ board also said it commissioned an external review to examine the heart surgery program and said it would share its lessons from the review to help hospitals around the country avoid the same mistakes.

The moves come following the Tampa Bay Times investigation that highlighted a growing number of heart surgery deaths at the hospital amid warnings about safety from staffers that went unheeded. (H)

“Three additional senior administrators have left Johns Hopkins All Children’s Hospital in the wake of a Tampa Bay Times investigation into high mortality rates at the hospital’s Heart Institute, the hospital announced Wednesday.

A total of six senior officials have left since the Times report, including the hospital’s CEO, three vice presidents and two surgeons who held leadership roles at the Heart Institute. A seventh official stepped down as chairman of the surgery department but remained employed at the hospital as a doctor.

The resignations announced Wednesday included vice presidents Dr. Brigitta Mueller, the hospital’s chief patient safety officer, and Sylvia Ameen, who oversaw culture and employee engagement and served as the hospital’s chief spokeswoman.

The hospital also said Dr. Gerhard Ziemer, who started as the Heart Institute’s new director and chief of cardiovascular surgery in October, would leave the hospital. The hospital never publicly announced Ziemer had been hired, and he had not yet obtained his Florida medical license when the Times investigation was published at the end of November. At that point, the hospital said the Heart Institute   had already stopped performing surgeries.

Sowers also announced that Johns Hopkins had hired external experts to develop a plan to restart heart surgeries at All Children’s.

That is a separate effort from an external review of the problems in the Heart Institute, which Johns Hopkins announced its board had commissioned last month, spokeswoman Kim Hoppe said…

Johns Hopkins is one of the most prestigious brands in medicine and is internationally renowned for developing innovative patient safety protocols that are used at hospitals across the world. But last weekend, the Times published a story detailing a series of safety problems at hospitals across its network. In response, the health system pledged to “do better.” (I)

“The Johns Hopkins Medicine Board of Trustees has appointed a former federal prosecutor to lead its investigation into the Johns Hopkins All Children’s Hospital’s heart surgery unit, the health system announced late Tuesday.

F. Joseph Warin, of the global law firm Gibson Dunn, and his team will review the high mortality rates and other problems at the hospital’s Heart Institute and report back to a special committee of the board of trustees by May, the health system said.

Once the review is complete, the health system said it would also name an independent monitor at All Children’s to “make sure that the hospital is being held accountable for taking corrective action where necessary.”

The announcement was accompanied by a video of Johns Hopkins Health System president Kevin Sowers, who acknowledged for the first time that the hospital had been warned about problems by frontline workers.

“I know personally that many of you courageously spoke out when you had concerns but were ignored or turned away,” he said. “That behavior is unacceptable and will not be tolerated going forward.”

Sowers, who is also interim president at All Children’s, said he hoped to meet with the families of patients affected by problems in the Heart Institute in the coming days to share his “profound sadness for the failures of care they experienced.” (J)

 “State and federal inspectors descended on Johns Hopkins All Children’s Hospital this week, following sharp calls for an investigation into problems in the hospital’s heart surgery unit, the Tampa Bay Times has learned.

The scope of the inspection is unclear. But hospital regulators had been criticized in recent weeks for their lax response to early signs of an increase in mortality at the hospital’s Heart Institute…

State and federal regulators knew the institute was having problems months earlier. In April, the hospital’s CEO told the Times that the institute had “challenges” that led to an uptick in mortality, and acknowledged the hospital had left surgical needles inside two children.

In May, state regulators cited the hospital for not properly reporting two medical mistakes, which is required by state law. Days later, a spokeswoman for the federal agency told the Times that it would perform its own investigation.

But state regulators didn’t fine the hospital, and overlooked several subsequent warnings that its surgical results had been poor.

And federal inspectors later changed course and decided not to undertake a comprehensive review of the heart surgery program, the Times reported last month. One reason was that state inspectors hadn’t found any violations of federal rules, a spokeswoman said. Another was that a nonprofit hospital accreditor was due to perform a scheduled review.” (L)

 “.. experience showcases the promise of a much-touted but little understood collaboration in health care: alliances between community hospitals and some of the nation’s biggest and most respected institutions.

For prospective patients, it can be hard to assess what these relationships actually mean – and whether they matter.

Leah Binder, president and chief executive of the Leapfrog Group, a Washington-based patient safety organization that grades hospitals based on data involving medical errors and best practices, cautions that affiliation with a famous name is not a guarantee of quality.

Brand names don’t always signify the highest quality of care,” she said. “And hospitals are really complicated places.”..

To expand their reach, flagship hospitals including Mayo, the Cleveland Clinic and Houston’s MD Anderson Cancer Center have signed affiliation agreements with smaller hospitals around the country. These agreements, which can involve different levels of clinical integration, typically grant community hospitals access to experts and specialized services at the larger hospitals while allowing them to remain independently owned and operated. For community hospitals, a primary goal of the brand-name affiliation is stemming the loss of patients to local competitors…

In some cases, large hospital systems opt for a different approach, largely involving acquisition. Johns Hopkins acquired Sibley Memorial and Suburban hospitals in the Washington, D.C., area, along with All Children’s Hospital in St. Petersburg, Fla. The latter was re-christened Johns Hopkins All Children’s Hospital in 2016…

Although affiliation agreements differ, many involve payment of an annual fee by smaller hospitals. Officials at Mayo and MD Anderson declined to reveal the amount, as did executives at several affiliates. Contracts with Mayo must be renewed annually, while some with MD Anderson exceed five years…

“It is not the Mayo Clinic,” said Dr. David Hayes, medical director of the Mayo Clinic Care Network, which was launched in 2011. “It is a Mayo clinic affiliate.”

Of the 250 U.S. hospitals or health systems that have expressed serious interest in joining Mayo’s network, 34 have become members.

For patients considering a hospital that has such an affiliation, Binder advises checking ratings from a variety of sources, among them Leapfrog, Medicare and Consumer Reports, and not just relying on reputation.

“In theory, it can be very helpful,” Binder said of such alliances. “The problem is that theory and reality don’t always come together in health care.”

Case in point: Hopkins’ All Children’s has been besieged by recent reports of catastrophic surgical injuries and errors and a spike in deaths among pediatric heart patients since Hopkins took over. Hopkins’ chief executive has apologized, more than a half-dozen top executives resigned and Hopkins recently hired a former federal prosecutor to conduct a review of what went wrong.

“For me and my family, I always look at the data,” Binder said. “Nothing else matters if you’re not taken care of in a hospital, or you have the best surgeon in the world and die from an infection.” ” (Q)

PART 2. June 1, 2019. “The situation that the New York Times described in North Carolina parallels that at Johns Hopkins All Children’s Hospital in St. Petersburg, which stopped performing heart surgeries after the Tampa Bay Times reported on problems in the unit

 “Tasha and Thomas Jones sat beside their 2-year-old daughter as she lay in intensive care at North Carolina Children’s Hospital. Skylar had just come out of heart surgery and should recover well, her parents were told. But that night, she flatlined. Doctors and nurses swarmed around her, performing chest compressions for nearly an hour before putting the little girl on life support.

Five days later, in June 2016, the hospital’s pediatric cardiologists gathered one floor below for what became a wrenching discussion. Patients with complex conditions had been dying at higher-than-expected rates in past years, some of the doctors suspected. Now, even children like Skylar, undergoing less risky surgeries, seemed to fare poorly.

The cardiologists pressed their division chief about what was happening at the hospital, part of the respected University of North Carolina medical center in Chapel Hill, while struggling to decide if they should continue to send patients to UNC for heart surgery…

That March, a newborn had died after muscles supporting a valve in his heart appeared to have been damaged during surgery. At least two patients undergoing low-risk surgeries had recently experienced complications. In May, a baby girl with a complex heart condition died two weeks after her operation. Two days later, Skylar went in for surgery.

In the doctors’ meeting, the chief of pediatric cardiology, Dr. Timothy Hoffman, was blunt. “It’s a nightmare right now,” he said. “We are in crisis, and everyone is aware of that.”

That comment and others – captured in secret audio recordings provided to The New York Times – offer a rare, unfiltered look inside a medical institution as physicians weighed their ethical obligations to patients while their bosses also worried about harming the surgical program.

In meetings in 2016 and 2017, all nine cardiologists expressed concerns about the program’s performance. The head of the hospital and other leaders there were alarmed as well, according to the recordings. The cardiologists – who diagnose and treat heart conditions but don’t perform surgeries – could not pinpoint what might be going wrong in an intertwined system involving surgeons, anesthesiologists, intensive care doctors and support staff. But they discussed everything from inadequate resources to misgivings about the chief pediatric cardiac surgeon to whether the hospital was taking on patients it wasn’t equipped to handle. Several doctors began referring more children elsewhere for surgery.

The heart specialists had been asking to review the institution’s mortality statistics for cardiac surgery – information that most other hospitals make public – but said they had not been able to get it for several years. Last month, after repeated requests from The Times, UNC released limited data showing that for four years through June 2017, it had a higher death rate than nearly all of the 82 institutions nationwide that do publicly report…

The best option, Dr. Kelly said, was to combine UNC’s surgery program with Duke’s. For years, physicians at both children’s hospitals talked informally about joining forces, but nothing came of it. They were “basically destroying each other’s capacity to be great,” Dr. Kelly said, by running competing programs less than 15 miles apart. But even combining the programs wasn’t an instant fix: It would take at least a year and a half, he said… (D)

“The situation that the New York Times described in North Carolina parallels that at Johns Hopkins All Children’s Hospital in St. Petersburg, which stopped performing heart surgeries after the Tampa Bay Times reported on problems in the unit…

UNC Health Care only made some of its death rate data public to the New York Times after numerous requests from the newsroom. The statistics showed that UNC’s children’s heart surgery program had one of the highest four-year death rates in the country…

UNC Health Care told the New York Times that the physicians’ concerns had been handled appropriately.

After the New York Times started reporting, the hospital ramped up efforts to find a temporary pediatric heart surgeon and reached out to families whose children had died or had unusual complications to discuss their cases…

The turmoil at UNC underscores concerns about the quality and consistency of care provided by dozens of pediatric heart surgery programs across the country. Each year in the United States about 40,000 babies are born with heart defects; about 10,000 are likely to need surgery or other procedures before their first birthday.

The best outcomes for patients with complex heart problems correlate with hospitals that perform a high volume of surgeries – several hundred a year – studies show. But a proliferation of the surgery programs has made it difficult for many institutions, including UNC, to reach those numbers: The North Carolina hospital does about 100 to 150 a year. Lower numbers can leave surgeons and staff at some hospitals with insufficient experience and resources to achieve better results, researchers have found.

“We can do better. And it’s not that hard to do better,” said Dr. Carl Backer, former president of the Congenital Heart Surgeons’ Society, who practices at Lurie Children’s Hospital of Chicago. “We don’t have to build new hospitals. We don’t have to build new ICUs. We just need to move patients to more appropriate centers.”

Studies show that the best outcomes for patients with complex heart problems correlate with hospitals that do a higher volume of surgeries – several hundred a year.

At least five pediatric heart surgery programs across the country were suspended or shut down in the last decade after questions were raised about their performance; a Florida institution run by the prestigious Johns Hopkins medical system stopped operations after reporting by The Tampa Bay Times in 2018. At least a half-dozen hospitals have merged their programs with larger ones to achieve more consistent results. And more institutions are considering such partnerships.” (E)

“North Carolina’s secretary of health on Friday called for an investigation into a hospital where doctors had suspected children with complex heart conditions had been dying at higher than expected rates after undergoing heart surgery.

Dr. Mandy Cohen, the secretary, said in a statement that a team from the state’s division of health service regulation would work with federal regulators to conduct a “thorough investigation” into events that occurred in 2016 and 2017 at North Carolina Children’s Hospital, part of the University of North Carolina medical center in Chapel Hill…

The investigation is in response to an article published by The New York Times on Thursday, which gave a detailed look inside the medical institution as cardiologists grappled with whether to keep sending their young patients there for surgery.” (H)

PART 3. Hopkins All Children’s Hospital/ North Carolina Children’s – pediatric cardiac surgery debacles.

“Johns Hopkins All Children’s Hospital has begun implementing some of the dozens of recommendations from a law firm hired to identify deficiencies at the hospital and its parent organization, Johns Hopkins Medicine, in the wake of high death rates in the St. Petersburg hospital’s pediatric cardiology program…

The recommendations focus on four key areas, said Dr. Kevin Sowers, president of Johns Hopkins Health System and executive vice president of Johns Hopkins Medicine.

He outlined those four areas in a video posted online. They are: strengthen the management and culture at Johns Hopkins All Children’s Hospital; improve processes for evaluating patient clinical quality and safety; clarify and streamline the reporting structure between the six Johns Hopkins Hospitals and the Johns Hopkins Health System; and review the ways in which the boards of Johns Hopkins All Children’s Hospital and Johns Hopkins Medicine should advance their governance responsibilities…

…In the coming weeks, the board of Johns Hopkins Medicine will appoint a monitor to track and report regularly back to them on the hospital’s progress.” (A)

“The recommendations for improvement include:

Prioritize a culture of absolute commitment to patient safety and of raising and addressing problems and concerns, including throughout the process of hiring and evaluating senior executives

Give physician leaders a stronger voice, create a more robust check-and-balance on the president

Better educate staff and faculty about JHM’s commitment to transparency and a culture of “see something, say something” and to improve channels to submit complaints and provide for independent review

Separate the medical staff office responsibilities from the patient safety and quality department responsibilities, which previously were overseen by a single vice president of medical affairs…

In the coming weeks, the board of Johns Hopkins medicine will appoint an external monitor to track and report back regularly to them on the hospital’s progress,” he said.

The initial focus will be on the St. Petersburg hospital, a team will go to the other five hospitals in the network to ensure the changes are taking place.” (B)

“The review recommended a commitment to patient safety and said the “see something, say something” culture is a vital part of that.

The hospital published the report on its website along with a video of Sowers talking about the results.

“Above all, we must work each and every day to support a culture in which each of us is supported and empowered to speak up and speak out,” Sowers said in the video.

He provided a toll free number where employees can anonymously report any issues: 1-844-SPEAK2US.” (C)

 “Children’s heart surgery departments across Florida will soon be subject to more oversight.

Gov. Ron DeSantis signed a bill late Tuesday that will let physician experts visit struggling programs and make recommendations for improvement…

The bill signed into law Tuesday makes significant changes.

It lets a committee called the Pediatric Cardiac Technical Advisory Panel appoint physician experts to visit Florida’s 10 children’s heart surgery programs. They will be able to examine surgical results, review death reports, inspect the facilities and interview employees.

Dr. David Nykanen, the chairman of the advisory panel and a pediatric cardiologist at Arnold Palmer Hospital for Children in Orlando, called site visits “crucially important,” especially when departments are having problems.

He said visits could start within the next six months…

The hospital has not yet resumed heart surgeries. The results of a review commissioned by the Johns Hopkins Medicine board are expected soon.” (E)

“A state regulatory process that limited the number of hospitals and some specialty services like transplant programs are going away on July 1.

Despite attempts by two hospitals, Central Florida doesn’t have a pediatric heart transplant program. But that could change in the coming years because a state regulatory process that limited the number of hospitals and some specialty services like transplants is going away on July 1.

For nearly five decades, the program known as certificate of need has required hospitals to get authorization from the state before building new facilities or offering new or expanded services — a complicated process that’s costly, includes reams of paperwork and potential challenges from competitors, and can take months or years…

Starting July 1, general hospitals are no longer required to obtain a certificate of need to build a facility or to start services such as pediatric and adult open heart surgery, organ transplant programs, neonatal intensive care units and rehab programs…

The second part of the bill goes into effect on July 1, 2021, when the certificate of need requirement will be eliminated for certain specialty hospitals such as children’s and women’s hospitals, rehab hospitals, psychiatric and substance abuse hospitals and hospitals that offer intensive residential treatment services for children.” (F)

“Cohen announced late last week that she had assembled a team from the state Division of Health Service Regulation, which licenses and oversees health care facilities, to “conduct a thorough investigation into these events.” They are coordinating with the U.S. Centers for Medicare & Medicaid Services, a federal oversight agency…

Kelly Haight Connor, a spokeswoman for the state health department, said Monday it’s difficult to know how long an investigation will take. In other DHHS investigations, a team often interviews a range of people, from caregivers, staff and those in their care.

Wesley Burks, CEO of UNC Health Care since December 2018 and dean of the UNC School of Medicine, sent a five-paragraph email to staff on May 30 at 10:16 a.m. and attached the Times’ article he described as “critical of UNC Medical Center’s pediatric congenital heart surgery program.”

 “While this program faced culture challenges in the 2016-2017 timeframe, we believe the Times’ criticism is overstated and does not consider the quality improvements we’ve made within this program over many years,” Burks wrote in the email. “As the State’s leading public hospital, UNC Medical Center often gets the most complex and serious cases in its pediatric congenital heart program. For many of these very sick children, we are often parents’ last hope…

On Monday, UNC Health Care spokesman Phil Bridges released a “timeline of Continuous Quality Improvement within the program over the past 10 years.”

The timeline mentions a four-month period from June to September in 2016 in which “concerns and allegations against specific individuals in the Congenital Heart Program” were “independently investigated and reviewed” by the dean’s office and the chief medical officer.

“Allegations of misconduct and concerns determined to be unfounded,” the document states, adding “allegations against specific individuals and results of the investigations constitute personnel records, which may not be disclosed,” citing public records law.

An ongoing initiative, according to the document, calls for a Department of Pediatrics review after every death in the Pediatric Intensive Care Unit, including pediatric cardiac patients, to assess the care provided and evaluate any opportunities for improvement.” (G)

“UNC Health Care officials announced Monday they are halting the most complex pediatric heart surgeries following a report that raised serious safety concerns over a number of child deaths at UNC Children’s Hospital…

Officials from UNC HealthCare said in a statement they plan to create an advisory board of external medical experts and “pause the most complex heart surgeries” until that board and regulatory agencies review the program.

The external advisory board, which is expected to have members from the University of Southern California, the University of Michigan, University of Pittsburgh Medical Center and Nationwide Children’s Hospital, will examine the efficacy of the UNC Children’s Hospital pediatric heart surgery program and make recommendations for improvement. The group will report to the UNC Health Care Board of Directors.

UNC Healthcare officials said they are also developing a new structure to support internal hospital reporting and plan to publicly release Society for Thoracic Surgeons’ (STS) patient outcome data, make a $10 million investment in new technology and bring in new specialists as part of their efforts to “restore confidence” in its pediatric heart program.

“Our pediatric heart program cares for very sick children with incredibly complex medical problems, and our clinical team works tirelessly to help those patients return to normal, healthy and productive lives,” Wesley Burks, M.D., CEO of UNC Health Care said in a statement. “We grieve with families anytime there is a negative outcome and we constantly push to learn from those tragic instances.

UNC Health Care’s board also endorsed the creation of a pediatric heart surgery family advisory council to provide a voice for patients, family members and staff directly to hospital leadership…

Most recently, Johns Hopkins’ All Children’s Hospital came under fire for increasing mortality rates among heart surgery patients at the 259-bed hospital following a Tampa Bay Times investigation. Top leaders of that hospital ultimately resigned and Johns Hopkins’ board also said it commissioned an external review to examine the heart surgery program.

In 2015, St. Mary’s Medical Center in Florida closed it’s pediatric heart surgery program after a CNN investigation revealed it had a mortality rate of more than three times the national average. In 2009, Massachusetts General Hospital suspended its pediatric surgery program in the wake of surgical errors.” (H)

 “UNC Children’s Hospital should merge its pediatric heart surgery program with the same work being done at Duke Health’s Children’s Hospital, just 10 miles away. A common program would greatly enhance the treatment of children and babies in need of complex heart surgery.

As it is, UNC Children’s does 100 to 150 pediatric heart surgeries a year, a rate considered low volume. That makes it harder to recruit and retain surgeons and limits surgeons ability to hone their skills. It also makes it harder to maintain the other parts of the program, cardiologists, anesthesiologists and staff for a pediatric heart intensive care unit.

East Carolina University’s hospital faced similar challenges as it provided pediatric heart surgery at a low-volume level of 50 to 75 surgeries a year. Eighteen months ago, ECU started sending all its pediatric heart surgery patients to Duke. The change helped boost Duke’s volume to where it has done more than 800 surgeries in 18 months. During the same period, Duke has posted a 1 percent mortality rate, despite a caseload in which a third of the operations are high risk.

Unfortunately, UNC Children’s Hospital appears uninterested in combining resources despite overtures from Duke. In a statement Thursday, the hospital said, “While there have been discussions with Duke Health over the years about ways to collaborate across various pediatric specialties, there are no plans to combine our programs. Patients in this region benefit from having two world-class medical institutions located so close together. Our clinicians frequently collaborate with colleagues at Duke. We sometimes transfer patients to them and vice versa.

UNC Children’s would prefer to run its own pediatric heart surgery program as a matter of institutional pride and money — the most complex operations can cost a half-million dollars. But pride and money aren’t — or shouldn’t be — the primary concerns. What matters most is how to get the best care for children in this highly specialized and high-stakes area of medicine. To do that, North Carolina’s best hospitals should combine their resources and expertise.” (J)

Typically, with complex medical procedures, outcomes are strongly correlated with volume. That means that if a program does more procedures, it has more expertise, the healthcare team has more experience working together — and as a result, patients have better results. Larger programs often have better equipment and more personnel. Sadly, the pediatric surgery program at North Carolina Children’s Hospital was a low-volume center…

Powerful forces stand in opposition to the closure of low-volume centers. Low-volume centers are attractive because they are geographically convenient; patients do not have to travel long distances for their care. Some insurance coverage is regionally-restricted, and families without resources are unable to access high-volume centers. Low-volume centers are often staffed by entrepreneurial physicians who don’t want restrictions on their right to practice medicine. And their goals are often closely aligned with those of local political officials, who would like to imagine that low-volume programs can replicate the results at large medical centers. Perhaps most importantly, hospital administrators at low-volume centers do not wish to see their revenues slashed — and their leadership positions eliminated.

So the problem of decentralized medicine and low-volume centers is getting worse, not better. To an increasing degree, a larger and larger proportion of specialized procedures in the United States are being done at low-volume centers…” (N)

For an unabridged chronology, click on

PART 3. Hopkins All Children’s Hospital/ North Carolina Children’s – pediatric cardiac surgery http://doctordidyouwashyourhands.com/2019/08/part-3-hopkins-all-childrens-hospital-north-carolina-childrens-pediatric-cardiac-surgery-debacles/

NOTES

PART 1

G.Johns Hopkins promised to elevate All Children’s Heart Institute, by KATHLEEN McGRORY and NEIL BEDI, http://www.tampabay.com/projects/2018/investigations/heartbroken/all-childrens-heart-institute/

H.Top officials at Johns Hopkins All Children’s Hospital resign following reports of heart surgery deaths, by Tina Reed, https://www.fiercehealthcare.com/hospitals-health-systems/top-officials-at-johns-hopkins-all-children-s-hospital-resign

I.Three more All Children’s officials resign following Times investigation, by By Kathleen McGrory and Neil Bedi, https://www.tampabay.com/investigations/2019/01/02/three-more-all-childrens-officials-resign-following-times-investigation/

J.Johns Hopkins hires former prosecutor to investigate All Children’s Heart Institute,by Kathleen McGrory and Neil Bedi , https://www.tampabay.com/investigations/2019/01/09/johns-hopkins-hires-former-prosecutor-to-investigate-all-childrens-heart-institute/

Q.Community Hospitals Link Arms With Prestigious Facilities To Raise Their Profiles, by Sandra G. Boodman, https://khn.org/news/community-hospitals-link-arms-with-prestigious-facilities-to-raise-their-profiles/

PART 2

D.” Horrible complications are happening that you can’t explain.” ” We have to be honest with the patients.” ” It’s a nightmare right now.” Secret recordings captured physicians’ concerns that more children seemed to fare poorly after heart surgery. Their hospital kept doing the operations, by BY ELLEN GABLER, https://www.nytimes.com/interactive/2019/05/30/us/children-heart-surgery-cardiac.html?smid=nytcore-ios-share

E.In North Carolina, the New York Times reveals another heart surgery program in trouble, by Kathleen McGrory and Neil Bedi, https://www.tampabay.com/investigations/2019/05/30/in-north-carolina-the-new-york-times-reveals-another-heart-surgery-program-in-trouble/

H. Secretary Cohen calls for investigation into NC Children’s hospital, https://www.ncspin.com/secretary-cohen-calls-for-investigation-into-nc-childrens-hospital

PART 3

A.Johns Hopkins All Children’s releases ‘lessons learned’ from review, by Margie Manning, https://stpetecatalyst.com/johns-hopkins-all-childrens-releases-lessons-learned-from-review/

B.Law firm recommends Johns Hopkins hospital to make administrative, patient safety changes, by  Veronica Brezina-Smith, https://www.bizjournals.com/tampabay/news/2019/07/01/law-firm-recommends-johns-hopkins-hospital-to.html

C.Johns Hopkins All Children’s Hospital Faces More Changes, by Julio Ochoa, https://wusfnews.wusf.usf.edu/post/johns-hopkins-all-childrens-hospital-faces-more-changes

E.Extra oversight for children’s heart surgery signed into law, by By Kathleen McGrory and Neil Bedi, http://www.tampabay.com/investigations/2019/06/26/extra-oversight-for-childrens-heart-surgery-signed-into-law/

F.Hospitals, transplant programs could multiply in Central Florida with law change, by Naseem S. Miller, https://www.orlandosentinel.com/health/os-ne-health-florida-certificate-of-need-repeal-20190701-tujobp6zofe7dorx7jxhfwc37q-story.html

G.No timeline for state investigation into NC Children’s Hospital, by Anne Blythe, http://www.tampabay.com/investigations/2019/06/26/extra-oversight-for-childrens-heart-surgery-signed-into-law/

H.UNC Children’s suspends complex heart surgeries after report raising safety concerns, by Tina Reed, | https://www.fiercehealthcare.com/hospitals-health-systems/unc-children-s-suspend-complex-heart-surgeries-after-report-raising-safety

J.UNC and Duke should unite on pediatric heart surgery, https://www.newsobserver.com/opinion/article231271418.html

N.Does Medicine Have a Wall of Silence?, by Milton Packer, https://www.medpagetoday.com/blogs/revolutionandrevelation/80256

PART 4

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