Soon after Cecilia Green's face caught fire during minor surgery, a shaken Dr. Prakash Vaidyanathan walked out of the operating room to explain what had happened to Green's waiting friend.
Later, the surgeon carefully dictated the details for Green's medical chart, explaining that he had already removed the small lesion on her forehead when a cauterizing tool he was using to stop the bleeding singed an eyebrow, touching off a blaze fed by Green's oxygen mask. "The whole face had caught on fire," he noted.
But because of a regulatory loophole common in many states, no one was required to tell the Maryland agency charged with protecting patients about the accident in December 2001 at Union Hospital of Cecil County. So until Green, 68, filed a lawsuit this year, no one did.
Beginning Jan. 1, however, Maryland's Department of Health and Mental Hygiene will require hospitals to report serious adverse events, including those caused by accidents and medical errors. The step comes nearly four years after a report from the nonprofit Institute of Medicine estimated that medical errors kill up to 98,000 U.S. hospital patients a year and recommended that the mishaps be studied to develop preventive strategies.
The state's intent is to identify broken processes: the misplaced scrawl on a medical chart that mentions a patient's allergy to a drug later given anyway. The damaged equipment noted but never fixed. The careful surgical plan that nonetheless ends in an astonishing way: with patients such as Cecilia Green in flames.
But making the regulations work to protect patients will be a colossal task. At least 21 states require hospitals to report adverse events, defined in the Institute of Medicine report as an injury resulting from medical management and not a patient's underlying condition. Even in those states, experts say, many such deaths and injuries never come to light. What's more, making sense of the flood of data can be difficult for regulators, who are stretched thin by limited budgets.
Many hospitals are working hard to protect patients without being forced, taking their cues from a growing mountain of research. But it is an attack that can be mounted only in increments. Veterans Affairs hospitals slap matching bar codes on patients and their medicines to avoid mix-ups. Doctors at Good Samaritan Hospital carry handheld computers to track patients' medical histories and avoid drug interactions. Johns Hopkins Hospital's intensive care unit nurses monitor residents to ensure that they wash their hands, helping reduce hospital-acquired bloodstream infections - a nationwide scourge.
Now Carol Benner, director of the Maryland Office of Health Care Quality, hopes her state's new regulations will encourage more hospitals to get serious about improving patient safety.
The rules, if implemented as drafted, will require hospitals to tell the state within five days of learning about adverse events that result in a patient's death or serious disability, defined as one that is present at discharge or lasts more than seven days. They will also require hospitals to thoroughly investigate why the events happened and provide within 60 days an explanation to the state, which plans to distribute alerts on how to avoid such problems.
Hospitals will also be required to tell patients when medical care has unexpectedly harmed them. And, for the first time, they will have to tell patients how to file a complaint with state regulators. Violators face loss of license or fines of $500 for each day they don't comply.
"It's going to be really important how we handle hospitals that don't report," Benner said. "That's where our sanction authority comes in."
Maryland is pushing ahead with mandatory reporting amid disagreement on whether it works. Studies show that hospitals don't report even all adverse events required by law, said Jill Rosenthal, a researcher for the National Academy for State Health Policy. That makes it difficult for states to identify - and try to prevent - recurring problems, she said.
Asked whether mistakes are commonly hidden in medical charts, Dr. Peter Pronovost, who leads Johns Hopkins' safety efforts and studies adverse events in intensive care units nationally, said, "Oh yeah, a ton."
Pronovost believes doctors and nurses won't feel comfortable disclosing mistakes unless hospitals stop expecting them to be perfect. He recalls an experience years ago when he withdrew a breathing tube from a patient who turned out to be unable to breathe on her own, temporarily depriving her of oxygen and causing brain damage from which she eventually recovered. When he talks about the incident at conferences, another doctor or a nurse will often walk up afterward and confess a long-buried mistake as if to a priest.
Now, he advocates telling patients what happened, apologizing and promising to fix whatever caused the problem so it doesn't happen again. "If I harm somebody, I have a moral obligation to tell the truth," Pronovost said. Speculating that some doctors hide patient injuries because they're afraid they'll be sued, he says, "What drives [legal] claims is families' perception of a cover-up."
Without mandatory reporting requirements, Benner's office learns about egregious cases through complaints or from hospitals that voluntarily report. As a result, Maryland regulators learn about relatively few incidents.
New York's 259 hospitals reported 28,689 adverse events in 2001, the most recent statistics available (New York believes a large number of cases still go unreported.) By comparison, Maryland's Office of Health Care Quality got 325 complaints of all kinds about its 56 hospitals in fiscal 2003.
The Maryland agency cited hospitals for deficiencies in 17 adverse-event cases from July 2000 through mid-March. Those provide a snapshot of the problems the state is sure to hear more about under mandatory reporting as well as of the suffering inadvertently inflicted.
Eleven cases involved deaths, with causes as varied as suicide and medication errors. In one, a 49-year-old man with a known allergy to the anti-psychotic drug Haldol died after he was given the medication anyway. In another case, a man died of sepsis after his colon was accidentally perforated during a colonoscopy, filling his abdomen with feces. A 28-year-old quadriplegic who was dependent on a ventilator died after it became disconnected. And an elderly woman died after tumbling from a reclining chair that her family had complained was defective.
Brenda L. Monaghan, 41, said she was disabled by pain for nearly two months after surgeons at Franklin Square Hospital accidentally left a 12 1/2 -inch retractor inside her during a hysterectomy in December. "I couldn't dress myself," Monaghan said, adding she was unable to bend because of pain. "My husband had to take care of me in the bathroom."
The retractor was removed only after it appeared on a CT scan after Monaghan's repeated complaints.
The state found that the mix-up happened when a scrub technician and a nurse were relieved for lunch during the operation. The nurse returned after the surgery and signed a report stating that the tools used had been accounted for, apparently assuming that the relief team had counted them.
Monaghan's case is among the kinds that New York requires hospitals to report and that Maryland soon will. Required to take corrective action, Franklin Square has revised its policies so surgical team members responsible for tracking supplies and tools can be relieved only one at a time, and then only after a count of surgical instruments has been done.
Some argue that the new regulations won't require hospitals to do anything different from what they already do other than report the results to the state. The Joint Commission on Accreditation of Health Care Organizations, which accredits about 80 percent of U.S. hospitals, requires hospitals to identify what went wrong in a serious adverse event and come up with a correction plan. But they aren't required to tell the commission about adverse events.
That the state will get the reports means hospitals will do better analyses, Benner said.
But some worry that Maryland regulators will be overwhelmed like Pennsylvania health officials once were. Pennsylvania had boxes of unanalyzed reports after it began enforcing its 1998 patient-safety law a few years ago, said Richard H. Lee, a deputy secretary at the Pennsylvania Department of Health.
New York, 18 years after beginning, is on the third generation of its mandatory reporting system for unanticipated patient outcomes in hospitals. Hospitals are now showing grudging acceptance for the Internet-based system by reporting an increasing number of incidents. But Arthur Levin, a consumer advocate, said New York's system is only now starting to yield useful comparative information.
Reporting an adverse event is just a start, said Dr. David M. Mazor, associate medical director at Long Island Jewish Medical Center in New Hyde Park. He spends much of his time trying to determine how errors occur at his hospital. After the hospital discovered that two laboratory specimens had been mixed up, Mazor trudged to the hospital's laboratory to play the role of gumshoe detective and retrace the samples' journey.
After Green suffered second-degree burns during surgery, Union Hospital did analyze what went wrong, said spokeswoman Kathryn McKinney. She declined to discuss the conclusions or whether the hospital changed procedures.
Green expected her surgery would take no more than 45 minutes. The plan was to go out to lunch afterward with her friend. Instead, she went by ambulance to a Pennsylvania burn treatment center with injuries to her larynx, trachea, lungs, face, neck and shoulder, her medical records show. She stayed eight days, spending much of it with her face wrapped like a mummy.
Vaidyanathan, according to medical records, first knew there was a problem when he noticed her right eyebrow singeing from the outside in, leaving a burn racing toward Green's oxygen mask. Seemingly instantaneously, her face ignited.
After learning of two similar incidents through mandatory reports, New York regulators discovered a pattern of such accidents. Using their database of adverse events associated with an electrosurgical tool - the kind used to cut or cauterize - officials found 95 incidents between April 1998 and April of this year, including 11 fires.
As a result, New York put out an alert in June telling hospitals how to avoid such problems. Among other things, the alert suggested coating eyebrows and other facial hair with water-soluble lubricating jelly to make them nonflammable. It also said, if possible, doctors should turn off oxygen for at least a minute before using a cautery, allowing the gas to dissipate.
Green still suffers from numbness around her mouth, has facial and shoulder scars from the accident, and says her voice has been permanently altered.
And though she says that Vaidyanathan came to visit her in the hospital and apologized, the two are now separated by the chasm of a lawsuit. Union Hospital, which denies liability, refused to pay for her $127,000 burn-unit bill, she said. Vaidyanathan's attorney said he followed accepted surgical practice and, despite the outcome, did nothing wrong.
"We all make mistakes, no matter how hard we try," a tearful Green said during a recent interview at her Earleville home. "But if something happens, then take responsibility."
Benner, whose office is reviewing the case after learning about it from a newspaper reporter, said regulators don't presume they can stop all adverse events from happening. But she said it's important the state know about those that occur - in hopes of preventing others:
"Stuff happens in hospitals. But it's what you do about it that can make a difference."