States target serious medical errors that never should happen

Hospitals and physicians hope these new laws will help improve patient safety, while not giving plaintiffs' lawyers another hammer.

By Kevin B. O’Reilly — Posted Jan. 2, 2006

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Late last year, Illinois became the fifth state to enact a law or rule requiring hospitals to publicly report so-called never events -- serious errors that patient safety experts say never should occur, for example, wrong-site surgery.

With several more states examining the idea, it appears the never-events approach to improving patient safety could supplant the broader medical-error reporting laws already on the books in 27 states.

Experts say the new laws are more focused and prevent discoverability in litigation, and thus will make it easier for hospitals to share patient safety strategies with each other.

The older laws generally require hospitals to report a much wider range of medical errors and don't specifically shield safety discussions from being discovered, according to the Health Policy Tracking Service, started by the National Conference of State Legislatures but now owned by an independent publishing firm.

"The broader statewide reporting initiatives have been a waste of time and money," said Robert Wachter, MD, editor of the patient safety journal AHRQ Web M&M. "Every hospital in the United States, even the best, has hundreds of errors each month, and there is no value to accumulating hundreds of thousands of reports in some bureaucracy. The key thing is: How do reports generate action?"

The new Illinois law, like the Minnesota, Connecticut, Indiana and New Jersey measures that preceded it, has at its core a set of National Quality Forum-endorsed consensus standards developed by groups representing physicians, researchers, health insurers, employers, workers and consumers. The Illinois legislation covers 24 of the 27 NQF standards.

The Illinois measure, like its brethren, narrowly targets well-defined events that kill or seriously injure patients. The law requires the state to publicly report only the number and type of serious errors annually. It also protects safety strategy discussions between hospitals from legal discovery. Identifying information about adverse events also is protected.

"It strikes the proper balance between the public's right to know about the quality of care provided in institutions where patients are receiving care with the need for physicians and hospitals to feel that their efforts to bring these incidents to light will improve quality without creating the blame atmosphere that can lead to litigation," said Craig A. Backs, MD, president of the Illinois State Medical Society, which supported the law.

Under the new law, hospitals must report a serious adverse event to the Illinois Dept. of Public Health within 30 days of discovering it. They have another 90 days to do a root-cause analysis and file a corrective action plan. The state health department will analyze the data and hospital plans for patterns and make recommendations to hospitals around the state.

Beginning in January 2008, the health department will issue an annual public report listing the number and type of never events, both in the aggregate and by hospital. The report also will recommend changes to reduce serious errors.

A number of patient safety experts agreed that the never-events laws are a promising approach.

"If you begin too big, you can get overwhelmed and then you're busy managing the reports and not managing the learning," said Jim Conway, of the nonprofit Institute for Healthcare Improvement in Cambridge, Mass. "A great place to start is never events."

The state has the option of later expanding the law to a broader focus. "But first we need to figure out how to never-proof every hospital in Illinois to make sure these events never happen," Conway said."It will take work, talent and tenacity, but if they eliminate never events in Illinois it will be a tremendous accomplishment."

In 2003, Minnesota became the first state to pass a never-events law. The state's first public report issued in 2005 revealed that 99 never events were reported between July 1, 2003, and Oct. 6, 2004, resulting in 20 deaths and four serious disabilities.

Connecticut hospitals reported 72 never events between July 1, 2004, and Sept. 14, 2005, according to a report the state's health department released in October 2005. The Connecticut law does not report hospital-level results. Other states with never-events laws have yet to issue reports.

Medical leaders in Minnesota and Connecticut, though very hopeful, said it's still unclear how effective the never-events approach will be.

"It's too early to tell what is occurring from this," said Robert Meiches, MD, CEO of the Minnesota Medical Assn. "People are optimistic, but there has not been enough cycle time to make a determination if there's been a benefit to patients and, if so, how much of a benefit."

Still, Dr. Meiches said that hospital groups in other states have contacted him about following Minnesota's lead. Steve Brenton, president of the Wisconsin Hospital Assn., said his group may lead an initiative this year to get a never-events law passed, but with no public reporting.

The Institute for Healthcare Improvement's Conway said the goal, made possible by the national patient safety legislation passed last summer that the AMA strongly supported, could be a nationwide never-events database in which hospital administrators and physicians share knowledge on how best to avoid these serious, potentially fatal, errors.

Though data aren't yet in on how effective the never-events approach may be, Conway said the time for action is now.

"We don't have the luxury of time," he said. "The health care industry wants to, and needs to, send a message of urgency."

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Never events

Surgical: Surgery is performed on the wrong site or wrong patient. A foreign object is left in a patient.

Product or device: Contaminated drugs or devices are used. Improperly used catheters, infusion pumps or ventilators cause a death or disability.

Patient protection: A baby is discharged to the wrong person. A patient commits suicide.

Care management: A wrong drug, wrong dose or a drug administered to the wrong patient or at the wrong time causes a death or disability.

Environmental events: Wrong or contaminated gas is administered. An electric shock, burn or fall that occurs in the hospital causes a death or disability.

Physical security events: An imposter physician, nurse, pharmacist or other medical staff member provides care. A patient is abducted or is sexually or physically assaulted.

Source: Illinois Hospital Assn.

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Most common serious errors

Minnesota and Connecticut have issued reports detailing the number and types of "never events" that hospitals reported to them as required under their new patient-safety laws. Here are the five most commonly reported never events in each state.

Minnesota (reporting period: July 1, 2003, to Oct. 6, 2004)

  • Foreign object in a patient after surgery or other procedure: 31
  • Stage 3 or 4 pressure ulcers acquired after admission: 24
  • Surgery performed on the wrong body part: 13
  • Patient death associated with a fall in the hospital: 8
  • Medication error resulting in patient death or serious disability: 6

Connecticut (reporting period: July 1, 2004, to Sept. 14, 2005)

  • Stage 3 or 4 pressure ulcers acquired after admission: 21
  • Foreign object in a patient after surgery or other procedure: 17
  • Medication error resulting in patient death or serious disability: 7
  • Wrong device used, resulting in patient death or serious disability: 7
  • Physical assault on hospital grounds resulting in the death or significant injury of a patient or staff member: 5

Sources: Minnesota Dept. of Health, Connecticut Dept. of Public Health

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