According to the Agency for Healthcare Research and Quality, the term "never event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum, in reference to particularly shocking medical errors (such as wrong-site surgery) that should never occur. Over time, the list has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability) and usually preventable.
1. Artificial insemination with the wrong donor sperm or donor egg
2. Unintended retention of a foreign object in a patient after surgery or other procedure
3. Patient death or serious disability associated with patient elopement (disappearance)
4. Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration)
5. Patient death or serious disability associated with a hemolytic reaction due to the administration of (certain types of) blood or blood products
6. Patient death or serious disability associated with an electric shock or elective cardioversion while being cared for in a health care facility
7. Patient death or serious disability associated with a fall while being cared for in a health care facility
8. Surgery performed on the wrong body part
9. Surgery performed on the wrong patient
10. Wrong surgical procedure performed on a patient
11. Intraoperative or immediately post-operative death in (certain types of) patients
12. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the health care facility
13. Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended
14. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility
15. Infant discharged to the wrong person
16. Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a health care facility
17. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility
18. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility
19. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates
20. Stage 3 or 4 pressure ulcers acquired after admission to a health care facility
21. Patient death or serious disability due to spinal manipulative therapy
22. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances
23. Patient death or serious disability associated with a burn incurred from any source while being cared for in a health care facility
24. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility
25. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider
26. Abduction of a patient of any age
27. Sexual assault on a patient within or on the grounds of the health care facility
28. Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the health care facility.
A Medicaid regulation in Missouri said that hospitals "shall report the occurrence of a serious reportable event and the root cause of the event" to a patient safety organization.
But a state official and the executive director of the Missouri Center for Patient Safety said the regulation doesn't actually mean hospitals have to make a timely report of adverse events.
"The process for reporting adverse events, and the outcome of doing that (or not doing that), is between the provider and the PSO per their contract," said Seth Bundy, spokesman for the Missouri Department of Social Services.
The Missouri center's executive director, Becky Miller, said the regulation doesn't include a timeline for when hospitals have to report the information. Fifty-four of the 147 hospitals that have contracts with the center, or about 37 percent, have made reports to the center about adverse events.
"Facilities that have not yet reported may not have experienced any such events or they may be going through internal processes to determine what and when to report the information," Miller said.
The Medicaid requirement may be changed.
Bundy said proposed revisions are expected to be made before the end of the year. Nothing is public yet.
CoxHealth spokeswoman Stacy Fender said she had been told that a "proposed regulation is pending that would remove the requirement for hospitals to report to a PSO."
Harold and Judith Gillham's phone in their Warsaw home rang a little after midnight Dec. 6.
It was the Springfield police department telling them Anthony Gillham, 34, hospitalized for depression, had hung himself.
Judith Gillham refused to believe that her stepson was dead -- until she saw his body.
"I touched him," she said. "I knew he was gone."
Gillham's suicide at the the Cox North psychiatric facility is what the health care profession sometimes calls a "never event," tragedies that are not supposed to happen in a health care setting. Such events also include surgery performed on the wrong patient or a woman dying in labor during a low-risk pregnancy.
Hospital patients and their relatives in Missouri and most of the United States have no way of learning about most adverse events. A federal website lists the rates at hospitals for some patient safety data such as accidental cuts and tears from medical treatment, but most adverse events aren't publicly reported.
In Minnesota, the state publicly reports adverse events by hospital online. Illinois plans to publicly report adverse events by hospital. They're part of a small but growing number of states trying to bring more transparency to hospitals and to the bad things that can happen in them.
Under a 2005 federal law called the Patient Safety and Quality Improvement Act, hospitals can report errors or other problems to patient safety organizations, but the reports are confidential. The reports aren't subject to subpoenas, records requests from disciplinary proceedings or requests from the media.
"Basically, they're swept under a rug," said D.K. Raymer, who founded a small patient advocacy organization in Springfield called HealthCare PSI.
Lisa McGiffert, who directs a patient safety initiative at the organization that publishes Consumer Reports, said the nonprofit had opposed the privacy provisions in the Patient Safety act.
"The law that created PSOs was out of step with where the country was heading," said McGiffert, who directs the Safe Patient Project at Consumers Union. "There was a movement across the country to be more transparent with medical harm and quality."
Health care officials said it's important not to publicly name hospitals that have adverse events because that can discourage employees from reporting problems.
"The idea is that if you can set up a no-blame culture where people can report freely that you will encourage reporting," said Dr. William Munier, the director of the Center for Quality Improvement and Patient Safety at the federal Agency for Healthcare Research and Quality
Hospital officials also fear lawsuits.
"You want to be transparent and report things, but you also don't want to open yourself to litigation," said Dr. Dan Sontheimer, the chief medical officer at CoxHealth in Springfield.
Dr. Ken Kizer, who coined the term "never event" while CEO of a health care nonprofit called the National Quality Forum, said if the hospitals are publicly named when bad events happen, patients may avoid hospitals and not get care.
"I tend to think that everything benefits from sunlight, but hospitals and health care providers are often disadvantaged because they can't talk about the specifics because of patient privacy rules," Kizer said. "In many of the cases, you don't know the full story until a complete investigation is made."
Even with privacy protections, many hospitals are reluctant to report adverse events to patient safety organizations.
In Missouri, about two-thirds of the hospitals in the state -- including St. John's and CoxHealth in Springfield -- haven't reported adverse events to the Missouri Center for Patient Safety in Jefferson City.
St. John's reports to a patient safety organization in California, the Quantros Patient Safety Center, to which all the Mercy hospitals in its four-state system report.
CoxHealth isn't reporting to a patient safety organization, but spokeswoman Stacy Fender said the hospital reports all required events to the appropriate state and federal agencies.
However, that doesn't create any sort of automatic public access into statistics about problems or statistics.
"The majority of hospitals in Missouri, including CoxHealth, are not currently reporting to a patient safety organization as Missouri regulations on this issue are currently in a state of flux," Fender said.
Springfield-area hospitals that do plan to report adverse events to the Missouri Center for Patient Safety are Citizens Memorial Healthcare in Bolivar and Ozarks Community Hospital in Springfield.
"For the good of patient safety, that's what you do," said Kim Tatum, the director of performance improvement at CMH. "You report them."
Kizer said the lack of data means that patient safety organizations, which are supposed to analyze the information and put out reports on how to improve conditions for patients, aren't as effective as originally hoped.
"A completely impartial observer, which I try to be, would say that they're of an indeterminate value at this point," said Kizer, now the director of the Institute for Population Health Improvement at the UC Davis Health System in Sacramento, Calif. "It's unclear what benefit is being achieved at this time, albeit a step in the right direction."
Munier, at the Agency for Healthcare Research and Quality, said there is no federal requirement that hospitals report adverse events to patient safety organizations. Most of the data that is reported doesn't include information about the population of patients affected which also means the patient safety organizations can't calculate most rates of adverse events.
"There's no ability for AHRQ to monitor the volume of the data," Munier said. "We are completely dependent on what happens out there at whatever speed it happens."
Sue Kendig, who served on the Missouri commission that helped lead to the Missouri Center for Patient Safety, said the center can still do useful data analysis with partial data.
"The purpose of the PSO isn't necessarily to do straight statistical reporting as you do in research projects," said Kendig, an associate professor at the College of Nursing at the University of Missouri.
Such research could include looking at ways to prevent common hospital errors.
"Doing good work"
Estimates indicate that problems with hospital care could be widespread. A federal report in November looked at "never events" and other adverse events among hospitalized Medicare patients.
The report, by the Office of Inspector General at U.S. Department of Health and Human Services, found that an estimated 13.5 percent of hospitalized Medicare beneficiaries, or 134,000 people during the month the report looked at, experienced some type of adverse event. An estimated 15,000 people died.
A leading Springfield malpractice attorney, Brad Bradshaw, sees a conflict of interest with the organizations connected to the Missouri Center for Patient Safety. Two of its founding organizations are the Missouri Hospital Association and the Missouri State Medical Association.
"Having this group do studies is completely unscientific and against all principles of medicine and science," Bradshaw said. "They are a biased group. It would be like having the tobacco industry do studies on whether cigarettes are harmful, and we know how that went."
But Munier said that the Missouri center is one of the leaders nationally among patient safety organizations.
"I think that the citizens of Missouri are fortunate to have that center there," Munier said. "They have been doing good work."
At St. John's, the hospital's policy on adverse events calls for the hospital to report to federal or state regulatory agencies as required by law and/or accreditation agencies as directed by the president and/or administrator.
"We support reporting these events to the appropriate agencies until such time as appropriate legal safeguards are in place which permit for wider public disclosure," Scott said.
When a hospital reports events to state or federal regulators, they sometimes become public. But that's unusual and infrequent.
That is, however, what happened with Gillham's death, which was reported to the Springfield police and investigated by the state Department of Health and Senior Services.
The News-Leader learned about Gillham's death through records requests to DHSS and reported his death in May, about five months after he died. An investigation found that employees falsified paperwork noting how often they checked on the safety of psychiatric patients, according to a report from DHSS. Six employees were terminated.
Gillham's father recently settled a lawsuit with CoxHealth for an undisclosed sum.
"We are greatly saddened by the events that transpired, and our thoughts continue to be with the patient's family," said Fender, the CoxHealth spokeswoman.
Judith Gillham said no one from the hospital system ever apologized to them. She and her husband plan to bury Gillham's ashes in Massachusetts near his mother.
"All I know is that my youngest son is gone, and we loved him," Judith Gillham said. "I find it very hard to find any justification on why he had to die. He was asking people for help."