Wednesday, June 3, 2015

Transparency

Some of the parents now torture themselves. They trusted the cardiologists who referred them to St. Mary's for surgery. Should they have asked more questions, searched online for the hospital's mortality rate?
 
They wouldn't have found anything. St. Mary's website heralded the arrival of "nationally renowned pediatric heart surgeon Dr. Michael Black" with glowing claims such as "smaller incisions -- improved self-esteem."
 
But there's no actual data. Unlike most other pediatric heart programs in Florida, St. Mary's does not publicly report its mortality rate
 
That's why CNN had to file a Freedom of Information inquiry to obtain the patient caseload data necessary to calculate the 12.5% death rate for open heart surgeries.
 
St. Mary's, owned by Tenet Healthcare, says CNN is wrong about the program's death rate, but refuses to say what it considers to be the right death rate...
 
.According to the documents CNN obtained from the state, from 2011 to 2013, St. Mary's Medical Center performed 48 open heart surgeries on children and babies. Independently, CNN determined that six infants died, and confirmed the deaths with parents of all six children. From those numbers, CNN was able to calculate the death rate for open heart surgeries as 12.5%, more than three times the national average of 3.3% cited by the Society for Thoracic Surgeons.

CNN reached Dr. Michael Black on his cell phone to ask about the babies who died after his surgeries.
 
"I hear you've been asking questions about me," he said. "You should come down here and we can talk."
 
He said a hospital spokeswoman, Shelly Weiss Friedberg, would be in touch to set a date for the meeting.
 
A few days later, Friedberg emailed to say Black wouldn't be doing an interview, and neither would hospital executives.
 
After St. Mary's repeatedly denied requests for interviews, CNN approached Davide Carbone, the CEO of St. Mary's, at his home. He shut the garage door without commenting...
 
CNN contacted Dr. Amit Patange, the cardiologist who referred Gomes to St. Mary's for surgery to ask why he had chosen to refer Davi's mother to St. Mary's, given that heart doctors in the area had been concerned about the program for many months and there were two other nearby hospitals with success rates at or better than the national average.
 
Patange said to call St. Mary's and hung up the phone...
 
By the middle of 2014, the state of Florida had been warned several times by highly respected experts that there was trouble at the children's heart surgery program at St. Mary's Medical Center.

See:  http://www.cnn.com/2015/06/01/health/st-marys-medical-center/index.html

13 comments:

  1. That's the case at more than half the hospitals that perform children's heart surgery -- they provide no data on how many of their patients live and how many die. CNN's review of hospitals is the first to assess transparency at programs that operate on children's hearts.

    Sixty out of the 109 hospitals fail to reveal such basic information. That's a stunning lack of transparency considering some 22,000 babies and children have heart surgery every year.

    Pediatric heart programs look impressive on their websites, with glowing claims and pictures of smiling children. But don't be fooled. According to data obtained by CNN from the Society of Thoracic Surgeons, among these 109 hospitals, the death rates range from around 1.4% to 12.1%. That's a huge difference in the number of children saved.

    "I feel like patients don't know what every physician knows: that there's a tremendous variation in the quality of medical care out there," says Dr. Martin Makary, a professor of surgery at Johns Hopkins University School of Medicine. "Some surgeons have impeccable records, and some have patterns of complications that are outrageous."

    The Society of Thoracic Surgeons, the largest professional organization for heart surgeons in the United States, said it "considers public reporting an ethical responsibility of the specialty." But when the group asked pediatric heart hospitals to report outcomes on its website, fewer than one out of three agreed.

    See: http://www.cnn.com/2015/06/01/health/heart-surgery-transparency/index.html

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  2. A baby who had heart surgery at St. Mary's Medical Center in Florida died Tuesday, at least the ninth infant to pass away after such a procedure since the program opened at the end of 2011.

    The same day the latest baby died, St. Mary's CEO Davide Carbone wrote a letter to employees about the CNN investigation, which aired Monday night, expressing support for the program and its heart surgeon, Dr. Michael Black.

    "The patients we serve are afflicted with severe life-threatening conditions, and it is impossible to eliminate the risk of mortality," he wrote.

    The hospital, which is owned by Tenet Healthcare, says CNN did not get the mortality rate right, but won't say what the hospital believes the correct rate is.

    "We are deeply saddened when a lack of institutional transparency may have contributed to potentially unnecessary risk and serious harm," said Amy Basken, a spokeswoman for the Pediatric Congenital Heart Association, a national advocacy group...

    Last year in April, the Florida Department of Health sent a team of expert heart doctors to St. Mary's to review the children's heart surgery program. The head of the panel, Dr. Jeffrey Jacobs, a professor of cardiac surgery at Johns Hopkins, suggested they stop doing heart surgeries on babies younger than 6 months.

    See: http://www.cnn.com/2015/06/03/health/heart-surgery-death-st-marys-hospital-florida/

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  3. Attorney Chris Searcy, who is suing Black and Tenet/St. Mary's on behalf of the two families, said he believes Black botched both children's operations.

    "It's so awful. I've never had a problem in 30 years," said Black in response.

    Searcy claims the heart unit failed in several ways and as a direct result of it's negligence, 4-month-old Keyari Sanders died, and Layla McCarthy was paralyzed in her lower extremities.

    Searcy also questions St. Mary's mortality rates.

    "We've had very good death rates. We've had lower death rates than other programs," said Black.

    Close to tears twice, Black said "they're" trying to demonize him. He said he has received threats and had his tires slashed six times.

    Of the children who died after surgery, Black said, "We've had one death this year. It's not unexpected. It's a tough business."

    Searcy said for his clients, it's much more than that. "They will never, as long as they live, stop hurting over what happened."

    See: http://www.wpbf.com/news/surgeon-under-scrutiny-for-childrens-cardiac-program-responds/33386042

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  4. St. Mary’s Medical Center was turned down the first time it applied to establish a pediatric open heart program.

    Competitors had objected, saying the West Palm Beach hospital couldn’t attract enough patients to have good outcomes. They rightly noted that children who need heart surgery are few and far between, and experienced surgeons and nurses are even fewer.

    CNN’s chilling recent report about children dying following surgery at St. Mary’s 4-year-old pediatric open-heart surgery program seemed to validate the naysayers’ concerns. But state data, reported Tuesday by The Post’s John Pacenti and Sonja Isger, shows different weighted mortality rates, of 4.58 percent for October 2011 to September 2014, compared with the state average of 3.97 percent. Notably, Arnold Palmer Medical Center in Orlando had the lowest pediatric open heart mortality rate during that period, at 2.86 percent. St. Mary’s had treated 80 pediatric open heart patients. Arnold Palmer had treated 353.

    See: http://opinionzone.blog.palmbeachpost.com/2015/06/04/would-repealing-hospital-con-law-lower-open-heart-deaths/

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  5. Palm Beach County Circuit Judge Meena Sasser relented Tuesday and recused herself from the case that centers on alleged malpractice in the pediatric cardiac surgery program at St. Mary’s Medical Center.

    Sasser twice refused to recuse herself when asked by the attorneys for defendant Dr. Michael Black, the head of the program who performed open heart surgery on 4-month-old Keyari Sanders.

    The child was one of nine who died after surgery and was the crux of a CNN investigation broadcast last month. The lawsuit was filed by Keyari’s mother, Ramona Strachan, who has said the St. Mary’s program needs to be shut down.

    Lawyers for Black said they planned to appeal the decision when Sasser refused to step down.

    Defense attorneys said Sasser sued St. Mary’s, among others, over the death of her infant son in 2002. The case compiled 14 volumes in the court clerk’s office. Sasser eventually settled with St. Mary’s.

    http://palmbeachhealthbeat.blog.palmbeachpost.com/2015/07/21/judge-recuses-herself-in-st-marys-case/

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  6. St. Mary's Medical Center in Florida announced Monday that it will permanently end its pediatric cardiothoracic surgery program, following a media report that stated the hospital's mortality rate of open heart surgeries is more than three times the national average. According to the medical center, "inaccurate" media findings were the reason for the closure of the program, which started in 2011...

    St. Mary’s released a statement Monday, announcing the shutting of the program. “We are proud of the work that has been done and the lives that have been saved. This is the decision of the hospital and not based on a decision or recommendation by the State of Florida or any regulatory agency,” the medical center said.

    "The inaccurate media reports on our program have made it significantly more challenging to build sustainable volume in our program. At this time we feel it is best to focus on other services needed by our community," the hospital said in the statement.

    CNN calculated the death rates under the program after filing records requests and confirming the deaths with parents of the infants. CNN also said that compared to other hospitals, St. Mary's performed low volume of pediatric surgeries, which can potentially lead to higher mortality rates. According to the Society of Thoracic Surgeons, cited by CNN, 80 percent of medical centers perform more than 100 pediatric surgeries a year and anything less than that is considered "low volume."

    However, the medical center said in June that the CNN figure was a “deeply flawed calculation” and alleged that the network arrived at the conclusion based on an incorrect assumption of the volume of surgeries performed at the hospital. The medical center also maintained that the program's mortality rate was in line with the national average.

    http://www.ibtimes.com/florida-hospital-closes-open-heart-surgery-program-after-report-high-infant-mortality-2057732
    Courtesy of: http://www.medpagetoday.com/Psychiatry/Addictions/53111?isalert=1&uun=g906366d4438R5793688u&xid=NL_breakingnews_2015-08-18

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  7. At least nine babies died after having heart surgery at the hospital since the program started in 2011. A 10th baby was left paralyzed.

    The surgeries and the deaths continued even after the chairman of an expert state panel recommended in June 2014 that St. Mary's stop doing heart surgeries on babies under the age of 6 months, and stop doing complex heart surgeries on all children.

    "We are proud of the work that has been done and the lives that have been saved. This is the decision of the hospital and not based on a decision or recommendation by the state of Florida or any regulatory agency," the West Palm Beach hospital said in a statement that was obtained by local media Monday.

    St. Mary's continued: "The inaccurate media reports on our program have made it significantly more challenging to build sustainable volume in our program. At this time we feel it is best to focus on other services needed by our community."

    After CNN's investigation was published, the hospital released a statement saying CNN's mortality calculations were "wrong," "exaggerated" and "completely erroneous" and that the program's risk-adjusted mortality rate was within the average range for pediatric heart surgery programs nationwide.

    The hospital also said then it would launch a comprehensive review of its pediatric cardiac surgery program and wouldn't schedule any elective pediatric congenital cardiac surgery cases until the review was completed.

    Calls to the hospital seeking additional comment Monday were not immediately returned.

    http://www.cnn.com/2015/08/17/health/st-marys-medical-center-investigation/index.html

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  8. “CNN’s reckless reporting has deprived the community of a vitally important medical program,” said Libby Locke, an attorney for Dr. Michael Black. “Dr. Black has retained our firm to prosecute defamation claims against CNN for the false and damaging statement in their deeply flawed reports. We intend to hold CNN — and the individual journalists involved in preparing these reports — fully accountable for the inaccurate, misleading, and damaging claims.” The AHCA (the Florida Agency for Health Care Administration), the regulatory authority in Florida, has rejected CNN’s reporting and slammed CNN for their “sensationalized” journalism. A fellowship trained, board-certified surgeon with over 25-years of experience, Dr. Black is an innovative, accomplished and respected surgeon, and he is a leader in the field. He remains a member in good standing on the medical staff at St. Mary’s Hospital.

    http://www.wptv.com/news/region-c-palm-beach-county/west-palm-beach/st-marys-medical-center-closing-pediatric-cardiothoracic-surgery-program

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  9. CEO Davide Carbone is resigning at St. Mary’s Medical Center.

    It's been a week of major changes at St. Mary’s.

    The latest change: chief executive officer Davide Carbone is out after 9 years at the helm.

    In a written statement, St. Mary’s said quote:
    “We appreciate Davide’s dedication to both St. Mary’s and the Palm Beach community for the last nine years and wish him well in his future endeavors. The future at St. Mary’s Medical Center is bright.”

    Carbone is leaving two days after St. Mary’s announced they were closing its Pediatric Cardiothoracic Surgery program.

    The children’s heart surgery unit and its lead doctor, Michael Black, came under fire, after a CNN report involving 9 infant deaths during a 4-year period.

    Some parents of infants who underwent surgery at St. Mary’s are suing.

    Attorney Chris Searcy of West Palm Beach represents two couples who have filed suit.

    “It doesn’t surprise me. it could’ve been because of what’s gone on with the pediatric heart surgery unit or it might not. I just don’t know. I believe Tenant Health Care Corporation opened a pediatric heart surgery unit and was operating upon 6 month old babies, critical surgery, that they were not up to standard to do,” said Searcy.

    Dr. Louis St. Petery, a Tallahassee physician who is the executive vice president of the Florida Chapter of the American Academy of Pediatricians, had this to say about Carbone’s departure.

    “This whole kids cardiac issue and the problems that it generated is a big deal to Tenet and I presume that played a very large role in the decision of the CEO to resign,” said Dr. St. Petery.

    Searcy says we may learn more about the reasons for Carbone’s resignation as the parents’ court cases wind their way through the legal system.

    http://www.cbs12.com/news/top-stories/stories/vid_28500.shtml

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  10. The heart surgeon at the center of the CNN exposé in early June that led to the closing of St. Mary's Hospital's pediatric heart surgery program and the resignation of hospital CEO David Carbone has fired back against the cable news network with a lawsuit alleging defamation, according to My Palm Beach Post.

    Michael Black, MD, the adult and pediatric congenital cardiothoracic surgeon at the West Palm Beach, Fla., hospital, filed a 208-page lawsuit against CNN in Palm Beach County Circuit Claims Court, claiming CNN "acted with actual malice when they published the defamatory June 1, 2015 article and video report," according to the lawsuit, and that "the preconceived goal of the June 1, 2015 article and video report was to manufacture an outrageous, headline-grabbing story about an incompetent, dishonest, and inexperienced doctor leading a surgical program in crisis and recklessly operating on young children to profit at the expense of those children's lives."...

    However, the lawsuit states the CNN defendants "knew at that time — and indeed, long before — that their defamatory statements about Dr. Black … were false, or at the very least, they recklessly disregarded the truth of those statements." The suit goes on to contend Mr. Carbone had informed CNN in a February 2015 letter that the mortality rate they had claimed for Dr. Black and the heart program was incorrect — more than three months before CNN published the article and video reports.

    "The data you provided does not represent all cases and/or procedures performed as part of the program," the letter said, according to Dr. Black's lawsuit. "The mortality rate that you have manually calculated is inaccurate, as it is calculated as a percentage of only a portion of heart operations performed by the program."

    Dr. Black, who is still on staff at St. Mary's, did not specify the dollar amount he is seeking in damages at trial, though he "seeks an award of compensatory damages for the reputational and economic harm caused by defendants' defamatory statements," according to the lawsuit.

    CNN responded to the lawsuit with a statement, according to My Palm Beach Post: "We intend to fight this in the courts. We will fight hard in defense of our reporting and we expect to prevail."

    Among the six defendants are CNN lead reporter Elizabeth Cohen, anchor Anderson Cooper, producer John Bonifield and employee Dana Ford, as well as Kelly Robinson, who contacted patients and nurses associated with Dr. Black, telling them he "kills babies" and leaves them "butchered" and "mangled," according to the report.

    http://www.beckershospitalreview.com/legal-regulatory-issues/st-mary-s-surgeon-files-defamation-lawsuit-against-cnn-for-reckless-disregard-for-the-truth.html

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  11. The doctor at the center of a CNN story that eventually led to the closure of the pediatric cardiac surgery program at St. Mary’s Medical Center struck back Tuesday with a remarkable defamation lawsuit against the cable news network.

    Dr. Michael Black’s meticulous 208-page lawsuit filed in Palm Beach County Circuit Court claims CNN — with wanton malice and reckless disregard for the truth — miscalculated the mortality rate for St. Mary’s fledgling program, reporting that it was three times the national average. Black’s lawsuit called the death rate calculation by CNN “a fundamentally flawed pseudo-statistical analysis.”

    The preconceived goal of CNN’s article and video report, according to the lawsuit, “was to manufacture an outrageous, headline-grabbing story about an incompetent, dishonest and inexperienced doctor leading a surgical program in crisis and recklessly operating on young children to profit at the expense of those children’s lives.”

    The CNN report sent St. Mary’s reeling and was the death knell for the pediatric cardiac program in August when the hospital’s CEO, Davide Carbone, also resigned. Black and the hospital have been named in malpractice lawsuits filed by parents of babies featured in the CNN video and article on its website.

    Nine babies died following heart surgery during the program’s brief existence, starting in 2011. But the suit claims that CNN knew — and was told repeatedly by St. Mary’s and others ahead of broadcast — that its calculated mortality rate was wrong and that the hospital’s real rate was in line with the national average.(continued)

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  12. (continued)Black, who is still on staff at St. Mary’s, did not specify a dollar amount to be sought at trial except to say he seeks compensation for “reputational and economic harm.”

    Lead reporter Elizabeth Cohen, as well as on-air talent and renowned anchor Anderson Cooper, are among six defendants in the 24-count defamation complaint, including a Jupiter Farms “heart mom” who played a big role in Cohen’s reporting and was the subject of at least two police complaints. Cooper featured the story on the air and on his show’s Facebook page.

    CNN responded to the suit in a statement: “We intend to fight this in the courts. We will fight hard in defense of our reporting and we expect to prevail.”

    The news network — in what the lawsuit alleges was a ratings grab with a story about babies with broken hearts — ignored Black’s prestigious background and the many successful operations he performed to focus on a handful of cases. Black is fighting at least two lawsuits filed by parents of infants who were operated on by the doctor and featured in CNN’s story.

    The lawsuit claims CNN’s story on St. Mary’s program and its many followups — reported on by The Palm Beach Post, USA Today and numerous other news outlets — has effectively ended Dr. Black’s career and even subjected him to death threats. In one example, a caller said Black would end up “butchered just like (his) patients.”...

    St. Mary’s program was essentially blackballed when many established cardiology practices refused to refer patients to Black and St. Mary’s. As a result, the program received primarily the most delicate and “undesirable” patients. “Dr. Black, however, never turned down a patient needing care,” his lawsuit states...

    As reported by The Post in several stories last summer, the data used in CNN’s report was widely disputed by the hospital and the state’s Agency for Health Care Administration. The lawsuit alleges Cohen purposefully ignored data that includes the risk level for each surgery, which levels the playing field for hospitals who care for the sickest children...

    St. Mary’s declined specific comment, but noted that it has rolled out updated data that shows the mortality rate was 4.9 percent — not the 12.5 percent rate reported by CNN...

    The lawsuit said CNN portrayed St. Mary’s as obstructionist and refusing answer questions when the network knew that the hospital was prohibited by federal law from commenting on a patient’s case without a waiver.

    One of the chief cases CNN used in its story involved an infant who was left paralyzed after the surgery. Black’s lawsuit points out that paralysis is a well-known risk of a coarctectomy even when performed well and that CNN failed to say other doctors reviewed the work and found Black performed up to standards.

    http://www.mypalmbeachpost.com/news/news/st-marys-surgeon-sues-cnn-jupiter-farms-heart-mom/nqRFR/

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  13. CNN's Anderson Cooper failed to have a defamation lawsuit claiming he sensationalized a story about dead babies thrown out of court.

    The judge argued the Florida doctor who is suing the network showed enough evidence to move forward with his legal battle on April 28.

    Last year, Dr. Michael Black filed a 208-page lawsuit against CNN and network host Anderson Cooper and senior medical correspondent Elizabeth Cohen, according to documents obtained by DailyMail.com.

    The doctor works at St. Mary's Medical Center in West Palm Beach, Florida and led a pediatric cardiac surgery program at the hospital.

    Anderson Cooper 360 ran segments that focused on the program and Dr. Black, which he claimed were fictitious in his defamation suit.

    The network published Black's photo and a headline that implied he treated 'babies as sacrificial lambs' and claimed he made a 'total mess with newborn babies.'

    Black accused the CNN of 'reckless disregard for the truth' by miscalculating the mortality rate for the program at St. Mary's.

    The report claimed the mortality rate of infants who died after heart surgery was 12.5 percent, which is three times the national average.

    The doctor said the calculations by CNN were 'fundamentally flawed pseudo-statistical analysis.'

    He believes CNN had a preconceived goal in reporting its story, 'to manufacture an outrageous, headline-grabbing story about an incompetent, dishonest and inexperienced doctor leading a surgical program in crisis and recklessly operating on young children to profit at the expense of those children's lives.'

    Cooper aired pieces about the hospital on the network. They ran the headline 'Secret Deaths: CNN Finds High Surgical Death Rate for Children at a Florida Hospital.'

    The story claimed a total of nine babies died following heart surgery under Black's program.

    However, Black claimed the producers were repeatedly told that the mortality rate they calculated was misleading and the hospital's mortality rate was in line with the national average of 3.3 percent.

    The CEO of the medical center allegedly told CNN the percentage they had calculated was inaccurate because it only accounted for a portion of the heart surgeries.

    http://www.dailymail.co.uk/news/article-4501372/Judge-allows-defamation-suit-against-Anderson-Cooper

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