A year after the Wisconsin State Journal examined patient-safety issues raised by the death in 2006 of Jasmine Gant at St. Mary's from a medical mistake by nurse Julie Thao, progress has been made but obstacles continue, patient-safety experts say.
"It's inching along," said Rod Hicks, a professor at Texas Tech University and former research manager at U.S. Pharmacopeia, a nonprofit organization that sets standards for the drug industry. "But these errors can still occur. We have not made the world a safer place yet."
Kendra Jacobsen, executive director of the Madison Patient Safety Collaborative, a joint effort among the city's hospitals and doctor groups, said the organization scrapped its task force on tubing misconnections last year because it became clear that tubing manufacturers need to take the lead.
The collaborative put on hold an effort to get Madison hospitals to use the same colors for medication bag labels, Jacobsen said, because some members thought it might hinder, instead of increase, safety.
"People rely on color a lot to do their work," she said. "If a nurse has worked for 20 years at one hospital, suddenly changing the colors one day could pose a safety risk."
Interchangeable tubing
Gant, 16, died during childbirth on July 5, 2006. According to state records, Thao mistakenly delivered an epidural anesthetic — a spinal drug that numbs the pelvic area — into an intravenous line in Gant's arm, where the teenager was supposed to receive penicillin for a strep infection.
Shortly afterward, Gant died. Her son, Gregory, survived.
Investigators said Thao, who pleaded no contest to two misdemeanors and lost her nursing license for nine months, ignored a pink warning label on the epidural bag, among other oversights.
Thao had worked two eight-hour shifts in a row and slept at the hospital before starting work at 7 a.m. the day Gant died.
A medical equipment vulnerability enabled her mistake: The top and bottom ends of epidural and IV tubing are interchangeable. That allows hospital workers to inadvertently give solutions to patients through the wrong tube and into the wrong part of the body, which can be deadly.
At least 1,200 tubing misconnections have occurred in hospitals in the past decade, an estimate that is likely very low, according to U.S. Pharmacopeia. Feeding tubes, bladder catheters, blood lines and other kinds of tubing are involved.
International issue
Dr. Frank Byrne, St. Mary's president, vowed after Gant's death to push for solutions to tubing misconnections. In an interview last month, he said the problem is complex.
"We have challenged manufacturers to change the tubing," he said. "But this is a national issue, and it's frankly tough to say how much traction we have had."
It's actually an international issue, said Jay Crowley, senior adviser for patient safety at the U.S. Food and Drug Administration.
Tubing misconnections could be prevented if medical device companies made different sizes or shapes of connectors for different kinds of tubing, Crowley and other experts say. But many companies sell tubing in several countries, and they want a global agreement on designs for new connectors, he said.
That's the charge of an international committee of regulators and manufacturers that met last September in London and this April in Washington, D.C. Another meeting is set for February in Berlin.
The Association for the Advancement of Medical Instrumentation, which sets standards for medical equipment in the U.S., is participating.
"It doesn't sound that complicated: Go make connectors," Crowley said. "But it's been a struggle to figure out how to do this."
It probably will take four to five years for the committee to resolve the issue, he said.
Feeding tubes
The committee and other patient-safety groups are focusing first on a particular type of misconnection: feeding tube and IV mix-ups.
A feeding tube set for babies in neonatal intensive care units has been on the market for a couple of years. The set, called Corflo, is incompatible with IV tubing. It was developed by Viasys MedSystems in Wheeling, Ill., which has its brain-device division in Fitchburg.
Patient-safety experts, including Hicks and Crowley, said this May in the first policy paper on tubing misconnections that more must be done.
"Many adult products can still be interchanged and connected to IV equipment," they wrote. "Without change to a 'forcing function' design, errors are not easily avoidable."
The paper was published in the Joint Commission Journal on Quality and Patient Safety. The Joint Commission, based in Oakbrook Terrace, Ill., is the nonprofit agency that accredits the nation's hospitals.
The commission in recent years has added patient-safety criteria to its hospital inspections. It has discussed making the prevention of tubing misconnections a requirement but has not approved the idea.
"It's on our agenda," said Dr. Peter Angood, the Joint Commission's chief patient-safety officer. "But this one is very complicated. It involves a variety of sectors of the industry."
Dr. Lucian Leape, of Harvard University, one of the country's top patient-safety experts, said the FDA should require manufacturers to make new kinds of tubing connectors.
"These are no-brainer kinds of solutions," Leape said. "It shows you how primitive our approach to safety is."
Crowley, of the FDA, said the agency likely will require new connectors once the international committee develops them.
Patient wristbands
In May, the Wisconsin Hospital Association made its first attempt to address another issue: the colors of patient wristbands. The colors can vary from hospital to hospital, causing confusion and increasing the risk for harm.
The hospital association said wristbands should be purple for "do not resuscitate," red for allergies and yellow for patients who might fall and hurt themselves. Identification wristbands should be white or clear.
Dana Richardson, the hospital association's vice president for quality, said the step is in response to a case three years ago in Pennsylvania. A nurse at an unidentified hospital mistakenly put a yellow wristband on a patient. Sometimes that means blood should not be drawn from that arm. But at that particular hospital, it meant "do not resuscitate."
The patient, who required resuscitation, nearly died before someone noticed the mistake.
Similar incidents have occurred in Wisconsin. A man was recently transferred from Upland Hills Health in Dodgeville, where he was given a blue identification wristband, to St. Mary's in Madison, where blue has meant "do not resuscitate," said Jacobsen, of the patient safety collaborative. Staff at St. Mary's promptly recognized the problem and removed the wristband, she said.
Medication labels
The colors of warning labels on medication bags are more complicated because health-care workers administer drugs so frequently, said Richardson and Jacobsen.
At Meriter Hospital and St. Mary's, pink labels are placed on bags of epidural drugs to warn that they should be given near the spine, not in the arm.
At UW Hospital and Madison's Veterans Hospital, the warnings stickers on epidural bags are yellow.
Meriter and St. Mary's use yellow stickers for the opposite reason — for drugs to be given intravenously, or in the arm.
Stickers on bags of drugs to be delivered intrathecally — closer to the spine than an epidural — are green at Meriter and pink at the Veterans Hospital. At UW, they were recently changed from red to purple. St. Mary's doesn't use such labels.
Jacobsen said the patient safety collaborative this month resumed talking about whether the colors should be standardized — or whether colors should be used on warning labels at all.
Long working hours
Nurses' working hours have not changed much in the past year, locally or nationally.
Meriter requires nurses who log 16 hours in a row to take 12 hours off before working again. At UW Hospital, nurses are offered the 12-hour interval but can opt out of it.
St. Mary's didn't have such a policy until a year ago, when it started requiring nurses who work 16 hours in a row to take 12 hours off before returning. Also, nurses at St. Mary's can no longer sign up in advance for double shifts as Thao had done for the day before her fatal error, Byrne said.
The state Senate this year discussed a bill to ban mandatory overtime for health-care workers but did not pass it.
The union that represents nurses at Meriter and UW negotiated bans on mandatory overtime in 2006. Administrators at St. Mary's, where nurses are not in a union, say they have never had mandatory overtime.
Regardless of policies on mandatory overtime, nurses say they frequently feel pressure to volunteer for extra hours.
If there's a sudden gap in staffing, "the reality is that somebody is going to have to stay," Andy Campbell, a nurse in UW Hospital's pediatric intensive care unit, said last year.
Renewed debate?
Nationally, a recommendation by the Institute of Medicine in 2004 to limit nurses' working hours has not been adopted. The institute, a nonprofit organization that advises Congress on health-care policy, said states should prohibit nurses from working more than 12 hours in a 24-hour period or more than 60 hours per week.
"No real action has occurred," said Ann Rogers, a nursing professor at the University of Pennsylvania. Her studies have revealed an increase in fatigue and errors among nurses who work more than 12 hours in a row.
"I don't think anything will happen soon because of the nursing shortage," Rogers said.
An Institute of Medicine committee is discussing the need for further reductions in working hours for residents, or doctors-in-training. Since 2003, residents have been limited to 80 hours a week and 30 hours in a row. Previously, more than 100 hours a week was common.
The renewed discussion about residents could prompt more debate about working hours for nurses, Rogers said.
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