Hidden Mistakes In Hospitals

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After a few weeks of nagging shoulder pain, Jonathan Faile of Fairfield drove with his wife to Bridgeport Hospital and walked into the emergency room early on the morning of Saturday, March 22, 2005.

An enzyme test indicated possible heart damage, so Faile's doctor prepared for a cardiac catheterization, a diagnostic procedure in which a thin tube is fed though an artery and advanced into the chambers of the heart.

One night in the hospital, the doctor assured, and then back to work on Monday.

But within hours, Faile was screaming in pain as blood gushed into his abdomen after surgeons accidentally cut his femoral artery. Soon afterward, with Faile's organs damaged by the excess pressure, doctors were bracing a stunned Justine Faile for the possibility that her husband might not survive the night.

He did. But over the next two months, Faile endured more than 20 surgeries, including the removal of virtually all of his large and small intestines, before Justine accepted that her husband could not be saved.

Jonathan Faile was 58 years old.

Under the state's "adverse event" reporting law, hospitals are required to inform the state Department of Public Health when patients suffer certain serious unintended harm. The legislation was intended to compel hospitals to improve care and help patients assess the quality of the state's medical facilities.

But since that law was revised five years ago, the mishap at Bridgeport Hospital, and thousands of other incidents that injured or killed patients, have been hidden from the public by hospitals and the state health department. From minor accidents to deadly errors, public access to hospitals' adverse events has fallen 90 percent since the legislature redrafted the law.

Hospitals now report a fraction of the mishaps they once revealed; Bridgeport Hospital, for example, concluded that Faile's case did not meet the criteria for reporting, although a spokesman said the hospital conducted its own internal review.

But even when hospitals notify the state, the health department keeps most of those reports secret.

The details of more than a dozen sexual assaults are concealed in the health department's files, along with at least 30 cases in which sponges or other objects were left in patients' bodies after surgery, a Courant analysis has found. Information on hundreds of serious falls is also kept under wraps by the department, as are the particulars of at least half a dozen cases in which newborns died or were seriously injured during childbirth.

>>Click here to contact The Courant's Investigative Desk

That secrecy was written into the law after hospitals balked at the state's original adverse-event legislation, which gave the public broad access to reports of medical errors and accidents.

The legislature in 2002 ordered hospitals to disclose all serious patient injuries "associated with medical management." But after the first reports were made public, hospital lobbyists persuaded lawmakers to rewrite the statute in 2004, limiting the types of adverse events that must be divulged and promising to keep reports secret unless they led to an investigation.

State health officials had given assurances that the new law would shed more light on serious medical errors. But an analysis of health department records, death certificates, medical examiner reports and lawsuits shows it has had just the opposite effect.

Since the law was revised:

•The state has investigated dramatically fewer adverse-event cases, with about three out of four reported events now closed without a formal inquiry — keeping them hidden from the public — including more than 50 cases in which patients died.

•Narrower reporting requirements have allowed hospitals to keep more medical mistakes secret even from state regulators, with reports to the state immediately dropping by more than half.

•Even after lobbyists pushed for more narrowly defined reporting rules, some believe hospitals still are not reporting all incidents mandated by law, but the state has never attempted to determine whether or not hospitals are complying.

"Do we know more? No," said Jean Rexford, executive director of the nonprofit Connecticut Center for Patient Safety. "The health care industry is as secretive as any you can imagine. And it doesn't serve the public well."

For any of the thousands of concealed cases, it is impossible under the law to know if they are hidden because hospitals are not reporting them or because the state has chosen not to investigate. But with fewer cases reported, investigated and made public, Rexford said, patients lack the resources to evaluate hospitals, and hospitals have less of an incentive to improve care.

"If there is a pattern of abuse, if there is a pattern of wrong-site surgery, of sponges left in, I think that it is in all of our interests to know which hospital is having that problem," she said. "And if it were public, I know that that hospital would change its systems to assure better outcomes. Sunlight works, and public shame also works."

>>Click here to search for details on 290 adverse-event reports investigated by the state Department of Health from mid-2004 through September 2009.

Secrecy And HonestyBefore the legislation was revised, health officials said they expected to investigate adverse events more frequently under the new law, because most of the incidents hospitals must report come from a list of more than two dozen "never events" that national health experts agree should never occur in a hospital.

Instead, the percentage of reported cases investigated by the state plunged immediately after the rewritten law took effect, ultimately dropping from about half of all cases to one in four, an analysis by The Courant shows.

Even in cases where patients have died, the department has closed the majority of them without an investigation. And for one hospital, Charlotte Hungerford in Torrington, the state did not investigate any adverse events during the first five years after the new law was enacted, according to records released by the health department.

Wendy Furniss, health care systems chief for the Department of Public Health, said it was closing more cases without investigating because, under the revised law, hospitals have provided clearer explanations of adverse events and how they plan to address problems. She said keeping the reports secret has made hospitals more willing to report honestly.

"The confidentiality piece has made all the difference," she said.

The department investigates cases that indicate systemic problems or inadequate standards of care, and Furniss said that with clearer initial reporting by hospitals, it is easier to rule out those problems without conducting an independent investigation.

The state, therefore, would not be inclined to investigate or make a case public if it appears, based on the hospital's version of events, that personnel recognized the problem, responded appropriately and made "the best out of a bad situation," she said.

A Courant analysis of thousands of death records and hundreds of lawsuits illustrates the disparity between potential adverse events and what is reported and investigated.

Death certificates, for example, include scores of cases in which possible medical errors — from medication mix-ups to mishaps during surgery — are identified as contributing causes in the deaths of hospital patients. But in only a handful of cases is there evidence that those events were investigated by the health department.

A Courant review of death certificates identified 24 hospital patients from mid-2004 through 2007 whose deaths were attributed in part to an unintentional cut during a medical procedure. But health department records show that no more than three of those deaths were investigated as adverse events. The remaining cases either were never reported by hospitals, or were reported but closed without an investigation, thereby keeping them secret.

In July 2005, for example, two 81-year-old women died at Hartford Hospital, and their death certificates identify the cause as an accidental cut during a medical procedure, with one woman dying of sepsis and the other as the result of blood pooling between her lungs and chest wall.

Timothy Lundgren, the son of one of the women, remembers the anesthesiologist crying when faced with the task of telling family members that the procedure had gone terribly wrong. "It was very traumatic for us," Lundgren said.

A hospital spokeswoman confirmed last week that neither case was reported as an adverse event, and said that under the current law, the hospital had no obligation to notify the state.

Likewise, more than 100 malpractice lawsuits are filed annually against Connecticut hospitals, and there is little apparent overlap between those cases and the cases known to have been reported to the state. Among the claims in those suits, some of which have been settled with cash payments:

•In November 2005, 77-year-old Alfred Povilaitis died at Yale-New Haven Hospital a day after a feeding tube was inadvertently placed into his lungs.

•In January 2006, a nurse at Middlesex Hospital accidentally flushed an IV line with insulin rather than the anticoagulant Heparin, causing 83-year-old Barbara Briggs to suffer a heart attack.

•In May 2007, 56-year-old William Sheldon bled to death at Lawrence & Memorial Hospital in New London after a surgeon allegedly improperly stapled his intestines during a surgical procedure.

A health department spokesman said it appeared each of those injuries and deaths also would not have to be reported under the law.

"People come to us because they don't know what happened to their loved one," said Joel Faxon, a malpractice lawyer with Stratton Faxon in New Haven. "They come to find out what happened to the dead because the hospitals and the department of public health aren't telling them."

Under the revised law, even deadly misdiagnoses are no longer reportable, and, with the exception of patients who develop severe pressure sores, harm caused by the inaction of physicians and others need not be disclosed.

In early 2005, doctors at Charlotte Hungerford Hospital wrongly told 62-year-old Michael Santopietro that he had lung cancer, which led to the removal of a portion of his lungs and an eight-day stay in the hospital. He now uses an oxygen tank.

"I was very mad," Santopietro testified during a malpractice lawsuit he filed. "I went through all this for nothing."

The hospital later settled for an undisclosed sum, and last May, a jury awarded Santopietro more than $1.5 million in his suit against the hospital's chief of pathology. But under the current law, the misdiagnosis was not reported to the state Department of Public Health.

"The criteria for reporting an adverse event is so carefully defined now that egregious cases that should require investigations don't get reported at all," said Faxon, the New Haven lawyer.

In November 2005, Linda Mae Smith, a healthy 52-year-old New Hartford woman, went to Hartford Hospital for surgery on her collarbone, which had healed poorly since she broke it falling off a horse more than a year earlier.

"I kissed my wife at 3:10 in the afternoon, and spoke with her and held her hand for a second as they wheeled her out," said Smith's husband, Bill Smith. "And that was the last I was able to be with her where she was Linda."

The surgery was uneventful. But during a 30-minute window in the recovery room, Linda Smith suffered a catastrophic loss of oxygen that went unnoticed until it was too late.

When doctors realized Smith was in trouble, they were able to quickly resuscitate her, according to her medical records. By the time the surgeon reached Bill Smith, the crisis seemed to be over.

"He was reassuring in his voice that things like this sometimes happen, and supposedly they resuscitated her and that everything is fine," Smith said.

But doctors later learned that she had been without oxygen so long that her brain was irreversibly damaged and she slipped into a coma. Months earlier, national news reports were consumed with the story of Terri Schiavo, the Florida woman kept on life-support against her husband's wishes. Bill Smith was haunted by images of Schiavo — contorted, motionless, unconscious.

"Basically, my wife didn't look any better than that," Smith said. "You just can't imagine turning the corner and walking in. You walk around that corner and here's this lifeless thing."

Neurologists at the hospital saw no signs of life, and 24 days after kissing his wife as she was wheeled to the operating room, Bill Smith signed the order allowing her to die.

Now, four years later, he keeps a photograph of Linda clipped to the visor in his car.

"This picture here I have above my visor," he said, displaying a photograph of Linda taken at a wedding. "So that every time the sun is shining and I have to put this down, I get to see my wife."

What he has not gotten are answers to questions about why his wife is dead.

"No one was saying anything as to what went wrong," Smith said. "I kept asking for answers and not getting any answers."

He won't get those answers from the state. The health department did not investigate Linda Mae Smith's death, and both the hospital and the health department say there was no requirement under the current law to report it.

"The state's reporting requirements are thoroughly understood and adhered to rigorously," said Hartford Hospital spokeswoman Lee Monroe, who added that "questionable cases" at the hospital are reviewed by senior management, and forwarded to the state if they meet the criteria for reporting.

Failure To ReportEven with narrower reporting requirements, advocates say there is still a significant problem with hospitals failing to disclose adverse events that are covered by the law.

That concern is based in part on a seminal report from the Institute of Medicine — released 10 years ago this month — estimating that 49,000 to 98,000 Americans die in hospitals every year from medical errors. Even at the low end of the report's estimate, the institute said errors occur in about 1 in every 35 hospital admissions, with 1 in 500 patients dying from a medical error. For Connecticut, that would amount to 12,000 errors and 800 deaths annually — dramatically more than the average 230 errors and 23 deaths Connecticut hospitals have reported in recent years.

While the 2004 legislation was prompted in part by concerns about underreporting, state health officials acknowledge that they have not tried to determine whether hospitals are following the law, and have never reviewed death records or lawsuits to help verify compliance.

"If you could send us a couple more statisticians, we'd love to do that," said Furniss, the state's health care systems chief. Later, however, she said she did not believe that the department had inadequate resources to enforce the law.

Health department officials say hospitals have a strong incentive to disclose all adverse events because the department would react harshly if it discovered a case in which a hospital did not report.

Department officials were able to find one case in which an unreported adverse event was discovered — a 2007 case at Hartford Hospital in which a patient died of a fatal reaction to a heart medication known for causing lung damage.

"I hope that means that hospitals are doing a good job of reporting," Furniss said of the single case.

Department records show the failure to report was one of 70 violations discovered by state health investigators during a series of inspections at Hartford Hospital. The hospital was put on probation and ordered to hire a consulting firm and improve numerous practices, but no fine was levied.

State epidemiologists classified the primary cause of the patient's death as "accidental poisoning by and exposure to other and unspecified drugs, medicaments and biological substances."

From mid-2004 through 2007, there were seven other patient deaths at Hartford Hospital, excluding deaths linked to drug abuse, with the same primary cause. Statewide, there were 72 other such deaths.

But even after discovering that Hartford Hospital had failed to report the death, state health officials acknowledge they did not investigate whether the hospital had kept other adverse events secret as well.

"Even a mandated reporting system is a voluntary system, unless you have audit capacity," said Arthur Levin, director of the Center for Medical Consumers in New York. "Without some way to ascertain the completeness and accuracy of the reports, you end up with data which, for comparative purposes, is puzzling. It's more than puzzling; it has the potential to mislead."

But a health department spokesman said adverse-event reports are not the only way the state learns of hospital mishaps.

"We have in place multiple mechanisms to monitor care provided in licensed institutions, including routine licensure and certification inspections, our public complaint process, the mandate for hospitals to report the loss of privileges by physicians and the adverse-event system," spokesman William Gerrish said. "Each time DPH conducts a federal survey, complaint investigation, licensure inspection or any other opportunity to review medical records at Connecticut hospitals, we are in essence auditing hospital compliance with adverse-event requirements."

Little Help For PublicA year after the 2002 law went into effect, Furniss said the state generally was satisfied with how hospitals were responding to the reporting requirements. But that changed after a 2003 Courant story describing errors reported by hospitals. Following that story, reporting dropped sharply, although Furniss told legislators that the sudden decline was not a backlash by hospitals, but the result of "confusion about the definitions."

Proponents of the 2004 revision said that by clarifying reporting requirements, it would eliminate disparities in reporting and allow meaningful comparisons among facilities.

But once the law was in place, it was not a comparison the department was willing to let health care consumers make.

"Some external factors may lead us to expect a higher number of reported events, even in facilities providing excellent health care," the department has written each year in its annual report to the legislature.

And for that reason, the department says year after year, it is keeping secret how many "never events" are reported by individual hospitals.

The best consumers can do under the revised law is compare the number of adverse events made public after an investigation by the state. For investigated cases, Yale-New Haven Hospital leads the state, with 35 completed investigations from mid-2004 through September 2009, followed by Hartford Hospital, with 26. For other hospitals in those cities, the Hospital of St. Raphael in New Haven had 18 cases investigated, and in Hartford, St. Francis Hospital and Medical Center had 17 investigations.

But with three-quarters of all reports kept secret, the number of investigations alone is not enough to meaningfully compare one hospital to another, said Levin, the patient advocate.

Connecticut health officials say secrecy is necessary to get hospitals to follow the law, and they say the current system has made a difference for patients.

"Several issues identified through adverse event reporting, such as falls, pressure ulcers, and hospital acquired infections, have led to special initiatives and interventions that we believe have reduced these adverse events and improved patient outcomes," said Gerrish, the health department spokesman.

But that is not what the department's own figures bear out. The numbers of reported falls and infections have remained steady over the last five years, and the number of reported pressure ulcers has risen dramatically, from 23 in the year after the new law, to 62 in the most recently reported full year.

Overall, there has been virtually no change in reported events, with hospitals filing between 228 and 247 reports in each of the first five years of the new law— with about 60 investigated each year, and the rest kept secret.

Particularly for "never events," Levin wonders why any reports are kept under wraps.

"Why are we even talking about confidentiality here?" Levin asked. "We're not talking about thousands of events here. We're talking about a relatively small number, and again we're talking about a relatively small number of things about which there is a consensus that they should never occur."

Copyright © 2014, Los Angeles Times
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