‘Pope’s hospital’ put children at risk as it chased profits

Among the AP’s findings:

— Overcrowding and poor hygiene contributed to deadly infection, including one 21-month superbug outbreak in the cancer ward that killed eight children.

— To save money, disposable equipment and other materials were at times used improperly, with a one-time order of cheap needles breaking when injected into tiny veins.

— Doctors were so pressured to maximize operating-room turnover that patients were sometimes brought out of anesthesia too quickly.

Some of the issues — such as early awakening and the focus on profits — had been identified in 2014 by the Vatican-authorized task force of current and former hospital doctors, nurses, administrators and outsiders. The AP corroborated those findings through interviews with more than a dozen current and former Bambino Gesu employees, as well as patients, their families and health officials. The AP reviewed medical records, civil court rulings, hospital and Vatican emails, and five years of union complaints.

On Monday, the hospital denied the AP’s findings and threatened legal action. It called the AP report a “hoax” that “contained false, dated and gravely defamatory accusations and conjectures that had been denied by an independent report of the Holy See.” It cited its reputation as a centre of excellence. It draws top-notch surgeons to work there and celebrity visits, including one by U.S. First Lady Melania Trump in May.

Vatican spokesman Greg Burke acknowledged the Vatican had investigated staff complaints and said it welcomes efforts to improve care, “including reports of practices that might be below standard.”

“No hospital is perfect, but it is false and unjust to suggest that there are serious threats to the health of children at Bambino Gesu,” he said.

Both the Vatican and Bambino Gesu pointed to the Vatican’s second investigation, led by American Catholic health care expert Sister Carol Keehan, as evidence that all of the allegations — except one involving space constraints — were false.

“While there are many things we could have missed or been misled about, we came away from this evaluation with a real sense that on the major charges and the major issues alleged, we have been able to disprove them,” Keehan’s report said.

The Vatican’s first investigator, though, fully stood by the findings he delivered to the Vatican in 2014.

“What we wrote in that report was the exact truth,” Dr. Steven Masotti said in a June 2 telephone interview. He said the hospital has its problems but that overall it has “very good standards.”

Facts are hard to come by in the secretive halls of Bambino Gesu, which does not make public financial details or publish its mortality and infection rates. Perched on a Roman hillside just up the road from Vatican City, the private hospital sits on Holy See territory and enjoys the same extraterritorial status as a foreign embassy — making the Italian taxpayer-funded institution immune to the surprise inspections other Italian hospitals undergo. It is financed by Italy’s public health system, but its main campus isn’t even technically in Italy.

There is no indication that the Vatican ever shared the results of either in-house investigation with the Italian health ministry, which in its 2015 recertification of its research activities reported that the hospital offered quality care “in such a way that assumes characteristics of excellence.” Provided with AP’s findings in December, the health ministry promised to investigate.

“If this is true, a myth has fallen,” the ministry’s then-spokesman Fabio Mazzeo said. “We have to verify.” Mazzeo’s successor, reached in June, said he had no further information, saying the hospital belongs to the Vatican.

All of the hospital employees who talked to the AP spoke on condition of anonymity, fearing they would lose their jobs if their names were used. Out of concern for the children, they said, they broke what the hospital’s union has called the “omerta,” the Italian code of silence.

Staff members told AP that some of the conditions they first reported in early 2014 have improved since the surprise resignation of Bambino Gesu’s president in 2015. The new administration, they said, focuses less on volume and shows more respect for protocols.

But some of the task force’s most important recommendations have not been implemented, including the replacement of the medical director. And in its July 2016 newsletter, the hospital’s main union said problems remain.

“Ten years ago, the ERs were jammed and they still are. Ten years ago, patients waited on stretchers and they still do. Ten years ago you entered with one illness and left with two hospital infections, and still do,” it wrote. “What has changed in 10 years? The machines are better, the pharmaceuticals are better, but the level of care is not.”

Pope Francis himself used the occasion of a 2016 Christmas audience with thousands of hospital staff members and patients to exhort Bambino Gesu not to fall prey to corruption, which he called the “greatest cancer” that can strike a hospital.

“Bambino Gesu has had a history that hasn’t always been good,” the pope said, jettisoning his prepared remarks to decry the temptation to “transform a good thing like a children’s hospital into a business, and make a business where doctors become businessmen and nurses become businessmen, everyone’s a businessman!”

“Look at the children,” Francis said in Italian, pointing to the young patients gathered at his feet in the Vatican auditorium. “And let each one of us think: ‘Can I make corrupt business off these children? No!’”

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“YOU HAVE TO PRODUCE, PRODUCE, PRODUCE”

The sequence of events that resulted in the two investigations began in early 2014, when the Vatican began receiving reports that the quality of care was suffering under the hospital’s then-president, Giuseppe Profiti. Since he was appointed in 2008, Profiti’s administration had been focused on boosting volume and opening satellite branches around southern Italy while cutting costs.

Vincenzo Di Ciommo Laurora, a retired Bambino Gesu epidemiologist, described the hospital’s culture at the time this way: “The more you do to a patient, the more money you bring in. You have to produce, produce, produce.”

As part of an unrelated study, he reviewed the charts of 11 cancer patients who had died and said he was struck by the “extreme number of medical interventions,” including kidney dialysis performed on children who were nearly dead.

“When these children don’t have any organs working, when nothing is working, when they’re full of infection, should we continue to do dialysis and heroic therapies?” he asked.

His concern reflected a long-standing ethical debate about when palliative care is more appropriate for terminally ill children — a debate that can be even more acute in a Catholic hospital.

Founded in 1869 by a Roman noble family to treat poor children, Bambino Gesu was donated to the Vatican in 1924 and has grown to become the main pediatric hospital serving southern Italy. In 2015, the 607-bed facility performed over 26,000 surgical procedures — more than a third of all children’s operations nationwide.

The Italian health service reimburses it for most of its services and a leaked audit reported that, in 2012 alone, the hospital received reimbursements and research grants that totalled 270 million euros ($290 million).

One of the main areas of expansion during the Profiti administration was in transplant services and oncology, where thousands of children have been successfully treated.

But in 2011, a 4-year-old with acute leukemia caught an infection, an extremely drug-resistant form of Pseudomonas aeruginosa, one of the leading causes of blood infections and pneumonia in hospitals. The outbreak infected 27 children and wore on for 21 months — from March 2011 to December 2012 — before the hospital brought it under control.

By then, eight children were dead.

“All wards of the onco-hematological department were involved,” Bambino Gesu staff wrote in 2014 in the journal BMC Infectious Diseases. The bug’s spread, they wrote, could have stemmed from the “hands of health care workers or use of non-critical medical equipment” — a clear violation of good hygiene practice.

All hospitals have problems controlling infections, many are plagued by overcrowding and even the best struggle to contain outbreaks of drug-resistant bacteria. But several experts contacted by AP called the Bambino Gesu outbreak “extreme,” unusual in its duration and rare for this particular strain to be found in children.

Nigel Brown, an emeritus professor of microbiology at the University of Edinburgh, said the problem should have been identified “within a matter of days” and that more aggressive management could have quickly confined the outbreak.

In a statement, the hospital said it was “absurd and specious” to cite the outbreak against the hospital, calling its infection control achievements “an example of good practice.” The hospital said it had successfully brought infection rates under international and national benchmarks in recent years, to an estimated 1.8 per cent last year, though it doesn’t publish the information in its annual reports.

Bambino Gesu’s union, a branch of Italy’s largest trade association CGIL, has repeatedly complained about hygiene problems, noting that the hospital has gone through five cleaning firms in as many years with unsanitary results.

In its November 2014 monthly magazine, the union noted that the neonatal surgery ward had “sadly become famous” internally for its rates of infection and death. Part of the problem, the union said, was the route some staff would take from the changing room to the ward.

“The path they have to take is equivalent to an open sewer, past garbage bins where various types of refuse are positioned,” the union wrote the previous month. “And we ask why hospital infections increase? If even such a simple problem is ignored, imagine those that are more complicated.”

In 2011, pharmacist Eugenio Ciacco wrote the hospital president to alert him that the pharmacy had stopped sterilizing needles and other equipment properly, a practice Ciacco said was leading to “extreme danger for the health of our young patients.”

Other staffers in the pharmacy reported related concerns: One told AP two common antibiotics intended to be consumed within a few hours sometimes were used for up to two days to save money.

In 2013, the hospital was ordered by Rome’s civil tribunal to pay 2.2 million euros to a family whose child was left partially paralyzed and brain-damaged by a hospital-borne infection in 2006 that wasn’t diagnosed or treated quickly enough.

Overcrowding and hygiene problems were still an issue in October 2015 when Federica Bianchi’s 17-month-old son Edoardo was treated for breathing problems in an ER examination room where she said other children had been receiving intravenous rehydration drips. Two days later, Edoardo began suffering bouts of severe diarrhea and vomiting. She didn’t know it then, but he had contracted rotavirus, an extremely common and contagious disease that can cause dehydration.

“He started to lose weight at the speed of light,” Bianchi said.

After Edoardo’s twin also caught the bug, she took both boys back to Bambino Gesu’s overcrowded ER. Twice over the coming days, staff sent her home with instructions to spoon-feed the boys water, even though Edoardo was so dehydrated his skin was “like parchment,” Bianchi said.

When the boys’ father returned from a trip, he took one look at the limp twins and took them to another hospital, where they were quickly diagnosed with rotavirus and isolated to contain the infection.

“I went to Bambino Gesu because I thought it was the best hospital in Rome,” Bianchi said.

She won’t go back.

Hospital spokesman Alessandro Iapino said there is no proof that Edoardo contracted rotavirus at Bambino Gesu, and added that germs are a fact of life in hospitals “because people are sick.”

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“AGAINST ALL ETHICS AND MORALS OF OUR HOSPITAL”

Among the most troubling of the task force’s findings, corroborated by the AP, was that surgeons were so pressed to increase turnover in the operating room that children sometimes came out of anesthesia too quickly, shedding tears or moving before surgery was completed.

A February 2014 internal hospital report said the attending staff was “considerably distressed” when a 14-year-old girl was awakened prematurely during an appendectomy. “The procedure performed by the anesthesiologist is against all ethics and morals of our hospital,” according to an “adverse event” report, filed when something goes wrong.

Anesthesiology isn’t an exact science and, even in the best hospitals, patients will occasionally awaken early.

Doctors normally start tapering off anesthesia in a procedure’s final stages or after surgeons have closed the wound. At Bambino Gesu, employees said, the process was accelerated, particularly for more minor operations such as hernias.

“It’s the rule of the day that kids are awakened a bit faster to try to do more operations,” one surgeon told AP. Other staffers interviewed by AP reported “early awakening” incidents prior to 2015, though none since.

It is unclear how frequently the incidents occurred, but the union wrote in its September 2013 newsletter: “Among surgeons and anesthesiologists, there’s almost a race in violating norms to please the eyes of the department head.”

Coleen McMahon, an American nurse who was a member of the first group investigating Bambino Gesu, said one employee told the task force that the practice resulted in babies shedding tears. Other staffers told AP that they saw children moving their limbs on the OR table before surgeries were completed.

“God, if you’re seeing what I’m seeing, please stop it,” McMahon recalled one task force member saying.

Experts say that while it isn’t rare to see tears during surgery, it’s a sign that more painkillers are needed.

“It suggests something traumatic is happening to the body,” said Dr. Phil Hopkins, a professor of anesthesia at Britain’s University of Leeds. “Seeing tears means that a patient is nearer to being awake than you would want them to be.”

Iapino, the hospital spokesman, labeled reports of “early reawakening” false and said the institution’s post-anesthesia procedures followed the best protocols. And the health ministry said in its 2015 recertification that the hospital’s outpatient clinic used a “particular anesthesia technique” where children are quickly awakened without pain.

Iapino also noted that the hospital has been certified for 10 years by Joint Commission International, a branch of the U.S.-based hospital accreditation organization. In 2015, JCI made its triennial inspection of Bambino Gesu, recertified it and promoted it based on its research.

The union newsletter, however, said JCI never saw the hospital under normal circumstances since its inspections are announced and staff prepared in advance: An informal survey by the union found that 55 per cent of hospital staff said they implemented all required protocols only when inspectors were visiting.

Iapino dismissed the union complaints as biased and said the allegations that prompted the Vatican investigations were dated and based on “rumours” by disgruntled and unqualified staff during a time of transition, following Pope Francis’ election.

The hospital responded to staff reports of cheap needles and syringes breaking prior to 2014 by saying it never ordered cheap needles, but that it does test new equipment in selected wards before buying it. It said 11 cases of faulty equipment had been reported to authorities in 2015 and 2016, and that in one case a syringe broke but that the child didn’t suffer any harm.

JCI did pinpoint several areas for improvement, including anesthesia and surgical care, infection prevention and control, medication management, patient safety and evaluating each staffer for the quality and safety of care provided, according to a JCI letter obtained by AP. Such recommendations are the norm, and Iapino said a follow-up visit would have occurred if JCI had found significant fault.

JCI also flagged informed consent from patients scheduled for surgeries. In some cases, the AP found, Bambino Gesu’s consent forms made no mention of specific risks or complications, standard at many hospitals.

Florinda Galasso knows now that the heart surgery she and her parents consented to in 2009 was riskier than they were led to believe. Her surgeon emphasized a 95 per cent success rate and scheduled the procedure for Dec. 23, assuring the 22-year-old that she would be back at college after Christmas.

But Galasso suffered a stroke — a recognized complication in open-heart surgery, made even more high-risk by her medical history. While the surgery itself was a success, the stroke left Galasso partially paralyzed on her left side. She can no longer drive, walks with difficulty and is nearly blind in her left eye. She abandoned her studies and moved back home.

Galasso, now 30, sued the hospital for lack of informed consent and won.

“Obviously, every operation has consequences,” she said. “But the possibility I might end up half-working? No one ever told me.”

In response, the hospital said the court merely found no proof of informed consent.

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“I WOULD ASSURE YOU THAT THE POPE HAS BEEN INFORMED”

McMahon, the American nurse, specializes in pediatric program development and visited Bambino Gesu in December 2013 to explore setting up a hospice program in Rome, saying she felt called by God to help terminally ill children.

“The conditions were horrific,” she told AP, adding that she was shocked by what she saw and heard from staff.

She wrote directly to Francis, who asked the Vatican secretary of state — the overseer of Bambino Gesu — to follow up.

“I would assure you that the pope has been informed and asked Cardinal (Pietro) Parolin to look into it,” then-Vatican official Monsignor Peter Wells emailed McMahon on Jan. 19, 2014.

Parolin soon asked Dr. Steven Masotti, an Italian heart specialist, to investigate. He formed the Independent Bambino Gesu Task Force, made up of about a dozen people, including McMahon. In three months of secret meetings at a Catholic college in Rome, Masotti interviewed dozens of current and former staff.

The task force acquired a stack of internal “adverse event” reports, which cited repeated violations of basic safety and hygiene protocols: missing signed consent forms, patients wheeled in for surgery without surgical gowns, staff in blood-stained clogs.

Staff provided back issues of the union’s monthly newsletter, which along with hygiene failures, noted nurses working 17-hour overnight double shifts.

In March 2014, the task force issued a devastating report that found breaches of accepted medical protocol, including overcrowding that caused increased infection risk, reuse of disposable equipment, early awakening from surgery, unsupervised experimental procedures and facilities that didn’t meet medical standards.

“The anomalies found seem to be amply diffused throughout the hospital, and according to many sources, are incentivized and rewarded by the administration with the aim of reducing expenses and increasing profit margins,” read a March 19 near-final draft obtained by the AP.

“But the worst thing, shared by all, is the loss of the unique rapport and welcoming and familiar atmosphere that existed in the past among doctors, nurses, young patients and their families,” it said. “This ‘modus operandi,’ which represented the true added-value of the hospital, seems today completely lost, substituted by an attitude aimed almost exclusively at profit.”

While finding Bambino Gesu’s health care results were comparable to other leading hospitals, the report criticized the “despotic” and intimidating administration and recommended a new medical chief of staff and nursing manager to better enforce medical protocols. It suggested creating a hospice program and revamping the ethics committee to vet experimental procedures.

“This proposal, if implemented, will significantly limit CEO’s power and cripple his ability to reduce the quality of childcare in order to increase revenues,” Masotti wrote McMahon in an email.

Several of the proposals were quickly implemented, including a revamped ethics committee. After an external audit in 2014 also confirmed a profit-motivated shift in mission, the hospital’s president, Profiti, resigned in January 2015.

In an interview with the AP, Profiti, now president of a private medical clinic in Campania, said he left to pursue new challenges and was proud of the results he achieved in seven years. He said he had heard about the 2014 task force but never saw its report. He laughed when AP read portions to him, questioning task force members’ competence and calling their conclusions “only rumours.”

After the task force finished its work, McMahon pressed the Vatican for action, drawing a swift rebuke from Masotti. “We are dealing with the Secretary of State of His Holyness (sic), the man that God Himself appointed to lead His Church. Is that clear?” Masotti emailed the task force on April 12, 2014. “Our job is over!”

But a few members went over his head and in September contacted Cardinal George Pell, the Vatican’s money czar, insisting that no substantive remedy had been applied to the “risky conditions” flagged months earlier by the task force, despite the “obvious danger” to children.

Pell, who last week was charged in his native Australia with criminal sex assault, then contacted Keehan, president and CEO of Catholic Health Association, an influential organization of 600 U.S. hospitals and health facilities, and asked her to investigate.

During a Jan. 27-30, 2015, visit to Rome, Keehan and an American doctor and nurse met with hospital board members and toured the main campus, armed with a laundry list of malpractice allegations. The trio interviewed the medical director and doctors and nurses on duty, communicating either in English or via a translator because none spoke Italian.

Keehan said she investigated reports of early awakening during surgery by asking doctors about their procedures and said they responded with “exactly the appropriate standard of care,” which she said “disproved” the employees’ eyewitness testimony that those protocols had been disregarded.

She said she looked closely at hygiene during her visit and that the cleaning procedures she observed during two OR changeovers looked thorough and appropriate and that the three OR schedules she reviewed weren’t too rushed. She acknowledged that overcrowding in the neonatal intensive care unit “may contribute to issues with central-line infections.”

She said she disproved the past reports by staff of cheap needles breaking by asking staff if they had the equipment they needed, and they replied that they did.

“We came expecting to have to do a big expose and we found no basis for those complaints at all,” Keehan said in an interview. “Can I say they’ve never made a mistake? Absolutely not. . But can I say that that is a hospital that gives exceptional care to children? Absolutely and positively yes.”

Keehan said she interviewed two hospital staffers on the task force. She told AP she didn’t find them credible and said they exaggerated claims and seemed to have a vendetta against the hospital. Indeed, the two had been fired and were ordered reinstated by Rome’s labour tribunal after a costly legal battle.

Keehan did not reach out to any of the 20 other active staffers whose names and numbers were provided by task force members. She said she did not review any union complaints, patient charts for the years and wards flagged as problematic, or any “adverse event” reports.

She said she didn’t think it was necessary because she was so convinced of the high quality of care she observed, which she said was in many cases “best in class.”

She told the AP she had not heard of the superbug outbreak that killed eight children.

When told of the American team’s investigation, the previous president, Profiti, initially said a three-day visit “seemed a bit short” to understand the complexities of a four-campus hospital. But when briefed on Keehan’s conclusions, he said she must have “quickly realized what kind of hospital it is.”

The president who succeeded Profiti, Mariella Enoc, promised a new era focused on patients, not power or profits. Under her leadership, staff report improvements, with less pressure to produce, new beds added to wards and renovated operating rooms. The hospital reported an 8 per cent decrease in the number of surgical procedures in 2015.

But complaints continued. In a 2015 open letter to the Vatican’s Parolin, who is in charge of Bambino Gesu, a group of doctors unaffiliated with the task force warned that staff would not comply with economic mandates “where numbers count more than the quality of excellent care.”

And as recently as last year, the National Association of Religious Hospital Doctors said that overnight on-call staff didn’t have adequate beds or bathrooms, violating norms meant to ensure rest and hygiene.

So when Francis publicly acknowledged problems during his Christmas audience, he was interrupted more than a half-dozen times by grateful staff applauding as he went off-script.

He told them that at his hospital, doctors and nurses must focus on children — and not fall prey to corruption.

“Corruption doesn’t just arrive one day. No. It slides in slowly. Today there’s a tip, tomorrow a bribe,” he said. “Slowly without realizing it, you end up with corruption.”

The Vatican never released a transcript of what he said at the session, which the AP filmed. Francis concluded with a denunciation of how the health care industry as a whole deceives the sick — and how the pope’s hospital must resist the temptation going forward.

“Sinners? Yes. We’re all sinners. All of us. But corrupt? Never.”

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Follow Nicole Winfield at www.twitter.com/nwinfield and Maria Cheng at www.twitter.com/mylcheng

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Nicole Winfield And Maria Cheng, The Associated Press

by Canadian Press

‘Pope’s hospital’ put children at risk as it chased profits

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