As state tries to improve reporting of hospital adverse events, level of patient harm unclear.
By Meredith Cohn, The Baltimore Sun
Nadege Neim won a $1.4 million verdict last year after suing her Ellicott City obstetrician for removing a healthy ovary and fallopian tube from her right side when she went into the hospital for surgery to have a cyst excised from her left.
A few years earlier, an unnamed man in his 50s sought treatment for pneumonia at a Maryland hospital and ended up losing both legs. No one properly assessed him, and scans that might have found the blood vessel blockage were delayed for nearly two days in a “cascade of poor decisions,” state regulators said in an investigative report obtained by The Baltimore Sun.
Such preventable medical errors kill more than 400,000 Americans each year and seriously harm at least 10 times that number, according to a recent study published in the Journal of Patient Safety.
But it’s impossible to know the full scope of the problem in Maryland.
While hospitals are supposed to report serious medical errors to state regulators, the mostly confidential system still doesn’t capture all of those happening in the Maryland facilities, patient safety experts and regulators acknowledge. Confusion over reporting rules and fear of legal or financial repercussions can thwart disclosure, they say.
Details about even the most severe and deadly mistakes, called “adverse events,” only become public if someone sues, or if regulators catch a hospital failing to report and launch an inquiry, the results of which are subject to open records laws.
“Are they grossly underreported? Shamefully, no one knows,” said Dr. Peter J. Pronovost, a leading patient safety expert at Johns Hopkins Hospital. “If you added up all the adverse events in hospitals, they would probably be about the third leading cause of death. The public should be screaming that we deserve better.”
As patients increasingly research their options for health care, consumer advocates are pushing for more transparency so patients can use information about medical errors when picking providers. Only Minnesota, New York and five other states have passed laws requiring that hospitals publicly report mistakes.
What information patients can find on medical errors at hospitals “is sorely lacking, unvalidated and without much meaning to the general public,” said Michael Bennett, who became a patient safety advocate after his 88-year-old father’s death. Six different bacteria infected his father’s blood and organs and destroyed a leg while he was being treated for a respiratory virus in 2004.
According to court records, Bennett, of Pikesville, unsuccessfully sued Sinai and Northwest hospitals and two doctors alleging wrongful death. The hospitals said at the time that they wouldn’t comment on litigation, but that they were taking various steps to prevent infections.
About the same time, the state began requiring its 66 acute care and specialty hospitals to report the most serious adverse events, such as wrong-site surgeries, falls, infections and advanced bedsores, to investigators at the Office of Health Care Quality, which licenses medical facilities.
The latest report from the office — which has drawn criticism after a disabled 10-year-old died at a group home it oversees — includes some information about egregious cases, including four patients oversedated to death, six who died when they fell and hit their heads and three premature infants fatally infected by catheters in fiscal 2013.
But it does not say where those cases occurred; that information is considered confidential. Regulators say they use the information to privately suggest improvements to hospitals and make overarching recommendations for all medical institutions.
And even the data that is collected may be flawed, because some kinds of mistakes appear to be under-reported.
For instance, Maryland hospitals reported that none of the millions of patients treated from 2004 to 2006 suffered from advanced pressure ulcers, or bedsores, an astonishing statistic given that bedsores are a common ailment caused by lying down too long.
After a push by state and hospital officials to improve reporting, the number increased to 144 in fiscal 2011 before falling to 52 in fiscal 2013.
But national statistics suggest that even those figures are low. Federal data show that, on average, about 0.6 percent of patients get bedsores that progress to the advanced state — a rate that would translate to more than 4,000 cases a year in Maryland.
Similarly, the number of bloodstream infections from central lines, or catheters, as reported to the Office of Health Care Quality appears low. Such infections have drawn special scrutiny in Maryland and nationally because they are preventable and deadly in up to half of cases.
The office received only nine reports in the last fiscal year of serious or deadly hospital-acquired infections of all kinds, a category that would include the bloodstream infections.
But other agencies found higher numbers. The Maryland Health Care Commission, another regulator, found 206 such bloodstream infections in hospitals in fiscal 2012, the last year for which data is available. And the Health Services Cost Review Commission, which sets hospital rates and penalizes those where complication rates are high, found 400 such infections in fiscal 2012 and 287 in fiscal 2013.
Hospitals are supposed to tell patients and their families of medical errors, but patients are not notified when their cases are reported to regulators. That has left many to believe they weren’t reported.
“I strongly believe the incidence is under-reported and that more public reporting of such errors would in fact help cut down on such mistakes,” Neim’s attorney, Andrew G. Slutkin, said after the verdict in the obstetrician suit. The $1.4 million award was reduced to $680,000 to comply with Maryland’s cap on non-economic damages.
He said that at age 31, his client, who declined to be interviewed for this article, was left with diminished fertility and faced a second surgery.
Officials at Saint Agnes Hospital, where Neim’s surgery took place in 2010, declined to discuss the case, citing patient privacy. Neim sued her obstetrician; the hospital was not named as a defendant in the lawsuit.
“Our institution complies with all regulatory reporting requirements, and we file the proper reports any time an incident requires such action,” the hospital said in a statement. “One part of patient safety is ensuring and confirming that all information related to our patients and their cases are kept in the strictest of confidentiality.”
Maryland General Hospital, since renamed the University of Maryland Medical Center Midtown Campus, failed to report the pneumonia case that led to a man losing his legs. It’s unclear how regulators learned about the events in 2009 and began investigating, though state officials said the hospital corrected the problems that led to it.
Hospital spokeswoman Mary Lynn Carver declined to discuss the case, citing patient privacy, but said such mistakes “are discussed and analyzed so hospitals can improve their practices and learn from each situation.”
But studies have revealed shortcomings in the way doctors and hospitals report errors.
According to a study by the U.S. Department of Health and Human Services inspector general, hospitals nationally fail to disclose 85 percent of errors and complications experienced by Medicare beneficiaries. The inspector general concluded that a lack of clear requirements was to blame and noted that hospital policies are rarely changed after mistakes.
In a survey by the journal Health Affairs, about a fifth of doctors said they had not fully disclosed an error to a patient in the previous year because they feared a lawsuit. Practitioners say rising malpractice costs add to the price of health care and drive up their insurance premiums.
Maryland regulators acknowledge that errors are still under-reported and are trying to boost compliance. They recently singled out bedsores as the most under-reported category in most hospitals.
A staff of five nurses in the Office of Health Care Quality has been charged with investigating the adverse events reported by hospitals, as well as complaints from patients.
Even though regulators don’t have the staff to follow up to ensure that hospitals make changes, the system has been useful, said Renee Webster, the office’s assistant director.
“Before the reporting law, we never learned about” the most serious errors and complications, she said. “Reporting allows us to look for patterns or procedures, breaks in the process or breakdowns in training.”
The General Assembly passed legislation requiring disclosure of medical errors to state regulators in 2001, the same year 18-month-old Josie King died at Johns Hopkins Children’s Center and her mother began pushing for changes at the hospital. The child came to Hopkins with severe burns and died from complications of dehydration that staff members failed to notice.
But state officials haven’t been required to routinely inspect hospitals for decades, instead focusing on complaints and errors. To maintain routine safety and quality standards, Maryland and other states only license hospitals that have a stamp of approval from an independent accreditation organization called the Joint Commission, which also does not reveal hospital-level findings.
The number of adverse medical events reported to state regulators has risen steadily, from 24 in fiscal 2004 to 365 in fiscal 2011 before falling to 223 in fiscal 2013. State law specifically shields the institutions from public disclosure of the cases to encourage reporting to authorities.
Questions of transparency
Lawmakers sought two years ago to further improve reporting of medical errors, in part by requiring audits that would assess the accuracy of hospital reporting and making data available to the public online.
But the bill didn’t gain traction and drew opposition from the Maryland Hospital Association.
Releasing the raw data for each hospital would discourage reporting, as the hospitals most aggressive about reporting would appear the least safe, said Carmela Coyle, president and CEO of the industry group. Instead, the information should be kept confidential and used to identify vulnerabilities in the system, she said.
“Hospitals work diligently on harm prevention,” she said. “We know, and research shows, errors can and do happen. … But we need to move away from a culture of blame.”
Del. Michael G. Summers, the Prince George’s County Democrat who sponsored the bill, said he believes better reporting would reduce errors and empower patients when choosing a hospital. He said that he wanted to give hospitals more time to make progress behind the scenes and has not decided if he will reintroduce the bill.
Colorado and Minnesota are among the states that report hospital-level data publicly. Officials in those states believe the extra transparency has reduced errors and informed the public.
Minnesota’s program was launched a decade ago to some hospital resistance, but Rachel Blake Jokela, the state’s adverse health events program director, said that “as time goes on they see that this is an even playing field and all facilities are doing it.”
On the federal level, Medicare has made limited data available on its website Hospital Compare to help consumers decide where to get care and encourage hospitals to improve.
But Dr. Martin Makary, a Hopkins associate professor of surgery who wrote the book “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Healthcare,” said that system isn’t particularly useful for consumers.
“People should expect some measure of performance accountability from their hospitals, but too often performance is unmeasured, unavailable or unreliable,” he said.
As part of the Affordable Care Act, Medicare and Medicaid officials began using billing data to penalize hospitals in 2012 for too many readmissions of heart and other patients. And in October, the hospitals will be fined when their patients obtain certain infections, bedsores, post-operative complications or other preventable conditions.
Meanwhile, Maryland hospitals are working to reduce medical errors and improve reporting. And the state has set a goal for them to reduce dozens of types of complications by 30 percent in the next five years as part of an arrangement with federal regulators.
The decision of when to notify hospital and state authorities is often difficult and less than straightforward, said Larry Raymond, clinical program manager of Howard County General Hospital’s Center for Wound Healing, where most patients have complications, including those resulting from a mistake. He said the hospital has begun encouraging staff to report potential errors.
“We don’t want to jump to any conclusions,” he said. “We try and talk to doctors, and if we determine something is missed, we have a liaison in the hospital to help go through the events that could have caused direct harm to the patient. In most cases, there isn’t obvious negligence.”
Teaching the nuances of reporting medical errors at Greater Baltimore Medical Center is patient safety officer Carolyn Candiello’s job. The hospital, cited in 2009 by regulators for failing to report that a 50-year-old patient developed a severe bedsore within 10 days of being admitted, has taken measures to step up disclosure, including hiring Candiello.
Two years ago, the hospital instituted an online incident-reporting system so staff could report concerns more easily and the information could be used to identify trends and improve hospital standards.
Last year the hospital also decided to voluntarily disclose some information about mistakes on its website each month, including charting the rate of “serious safety events.” CEO John B. Chessare contends that while hospitals have been reluctant to share the data, disclosure can lead to improved care, and in turn, lower the risk of lawsuits and loss of business.
At Hopkins, Pronovost directs a hospital institute on patient safety and is working with institutions around the country to develop better reporting systems. But that will take time.
“For now, the data is squishy,” he said.
Copyright © 2014, The Baltimore Sun