State systems for serious reportable events’ will require reporting, analysis

Similar to JCAHO’s sentinel events, but will be separate obligation

Now that you’ve gotten used to the idea of sentinel events, get ready for the state equivalent: the list of "serious reportable events" recently adopted by the National Quality Forum (NQF) in Washington, DC.

The list is similar to, but entirely separate from, the sentinel events list used by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The NQF, which developed the serious reportable events list, changed the name from "never events" because that sounded too harsh and allowed no flexibility in identifying the incidents. The NQF board recently approved the list of serious reportable events and will pass it on to other health care organizations for implementation.

Individual states will determine how and when to use the serious reportable events list, says John Colmers, a program officer at the Milbank Memorial Fund, an endowed national foundation in New York City that works with decision makers in the public and private sectors on issues of policy for health care and public health. Colmers worked with the NQF to develop the serious reportable events list and says the project was an outgrowth of the Institute of Medicine’s (IOM) report on medical errors, To Err is Human. That report called for a state-based system for reporting serious medical errors.

"The IOM study anticipated a two-tiered system for reporting medical errors," Colmers says. "One would be a mandatory system for reporting the most serious and egregious events at a state level. The second, and considered by IOM the most important, is a system of voluntary reporting."

The serious reportable errors list can be used for developing both mandatory reporting requirements and encouraging voluntary reporting. The Centers for Medicare and Medicaid Services (CMS), and the Agency for Health Care Policy and Research (AHCPR) funded the research. Colmers says the NQF’s job was to develop the list and then hand it over to CMS and the AHCPR for implementation.

The list looks like another version of the Joint Commission’s sentinel events but drawn up by a different committee. Critics are suggesting that the NQF’s new list duplicates the sentinel event system and will only create a dual track of reporting with unnecessary and redundant work.

According to the NQF report, the core set of events are "of concern to both the public and health care providers; clearly identifiable and thus feasible to include in a reporting system; and of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the health care facility." To qualify for this core list of serious reportable events, an event must be unambiguous, usually preventable, serious, and any of the following:

  • adverse and/or ;
  • indicative of a problem in a health care facility’s safety systems and/or;
  • important for public credibility or public accountability.

The NQF report says that the term "usually preventable" recognizes that some of these events are not always avoidable given the complexity of health care. "The presence of an event on the list, therefore, is not a priority judgment either of a systems failure or lack of due care," the report says.

There are 27 serious reportable events that should be reported by all health care facilities as they occur. The NQF emphasizes that individual incidents should be reported, not frequencies of events. The events are organized in six categories — five that relate to the provision of care (surgical, product or device, patient protection, care management, and environmental) and one category that includes four criminal events. These latter events involve illegal acts, or acts of misconduct, and the NQF says they are included because they could be indicative of an environment that is unsafe for patients. "Although a health care facility cannot eliminate all risk of these events — e.g., of assault — it can take various preventive measures to reduce that risk," the report says. (For the list of serious reportable events, see "NQF's list of 'serious reportable events'.")

The serious reportable events list was developed for individual state use, but there is no requirement that states adopt it or use it uniformly. The hope, though, is that many states will use the list as the basis for their reporting requirements.

"We’re certainly not going to have all 50 states doing this or doing it the same way," Colmers says. "We hope states will see this list as a good starting point for developing their own reporting requirements, while realizing that their data will be more useful if they are the same as that collected by other states."

Data to become more reliable

As states adopt the serious reportable events list, Colmers says the data on medical errors will become more and more reliable, with the ability to spot trends and regional problems. The NQF’s report on the issue says "the primary reason for identifying a standardized set of serious reportable events that would be mandatorily reported is to facilitate public accountability for the occurrence of these adverse events in the delivery of health care." It goes on to say that "Whether or how such data might be disclosed to the public after being reported to the responsible agency [e.g., in a de-identified manner, or in aggregated regional reports naming individual health care providers, etc.] is a policy decision for the states, although at least some degree of public disclosure is recommended."

Colmers emphasizes that "public disclosure" means reporting the incident to a government body, not necessarily making the incident public.

"States and health care providers should know that this is a mechanism that requires them to be publicly accountable for serious events and do some sort of root-cause analysis," he says. "Some states already have a system like this in place, or some rudiments of mandatory reporting. The great value of having a list like the one we’ve prepared is that it provides some guidance to states in collecting information in a uniform fashion."

Not everyone is looking forward to the serious reportable events being adopted by states. Ellison C. Pierce Jr., MD, executive director of the Anesthesia Patient Safety Foundation, urged the NQF not to adopt the list. Pierce wrote that his organization worries about "the nature of the bureaucracy that would be created to manage the aggregated reports from the states" and whether mandatory reporting would discourage providers from being forthright about errors. Kenneth Aaron, MD, medical director of Hoag Memorial Hospital Presbyterian in Newport Beach, CA, told the NQF that he and his colleagues support the goals of the list but don’t see why it is any different from the Joint Commission’s sentinel events program.

"The content of the list, and the express desire to employ root-cause analysis, prevention strategies, and dissemination of lessons learned to prevent recurrences either in the same or other institution, are appropriate but very similar to the requirements and philosophy of JCAHO accreditation," Aaron wrote. "If the JCAHO process is not providing the intended results, perhaps it can be modified, rather than employing another parallel system of reporting and aggregating data."

The Joint Commission insists that the new list of serious reportable events is not an effort to reinvent the wheel. Paul Schyve, MD, senior vice president of the Joint Commission, tells Hospital Peer Review that the Joint Commission participated directly in the NQF’s development process and sees the new list as a way to cover areas not covered by the sentinel event process.

With sentinel events, the Joint Commission looks at two categories: certain events that result in serious harm or death and trigger a Joint Commission investigation, and other events in which no one is harmed but nevertheless represent a serious failing, Schyve explains. An example of that second category would be an infant abduction in which the child was returned safely.

All of the sentinel events that would automatically trigger a Joint Commission review are found on the NQF list as well, and everything else on the NQF list probably would qualify under the broader definition of a sentinel event, he adds. There appears to be no conflict between the two lists, though the NQF lists more specific incidents than the sentinel event list, Schyve says.

The NQF list is much more extensive than the Joint Commission’s — 27 specific items vs. five incidents that automatically qualify as sentinel events. Schyve doesn’t say that the NQF list expands the sentinel event definition, but adds, "I don’t see anything on the serious reportable events that we wouldn’t consider a sentinel event."

So why is the new list necessary? Partly because the IOM report said a state-based reporting system was necessary and no one seems eager to counter that. But Schyve says the NQF list, if it is adopted widely by states, will take the philosophy behind the sentinel event system to a wider range of health care providers.

"It’s not the same as the Joint Commission’s system because the sentinel event system has only those who volunteer as participants," Schyve says. "The IOM report envisioned a mandatory reporting system, and if enough states adopt some form of the serious reportable events, we’ll have more providers participating than those volunteering for Joint Commission accreditation."

States must find ways to avoid duplication

Even if the two separate lists are necessary, there are legitimate concerns about duplication of efforts when a provider must report an incident, Schyve admits. Health care organizations already complain that reporting a sentinel event and conducting a root-cause analysis is burdensome, and now the NQF list suggests they might have to do it twice. That all depends on how states adopt the list, Schyve says.

"The problem of parallel tracks for reporting already has occurred in some states with mandatory reporting, and we want to work with states to avoid that," he says. "There’s no reason we can’t come up with systems in which the same information is reported using the same tools to satisfy the Joint Commission and the state reporting requirements."

The NQF team also worried that the serious reportable events could be a burden unless some way is found to coordinate with national requirements. "Until a standardized reporting framework is pursued, including coordination with existing voluntary and mandatory systems, the burden on individual health care providers and health care facilities to meet the requirements of divergent systems will be a source of frustration that wastes resources and diminishes the potential for public accountability and quality improvement," the NQF report says.

Multiple reporting within a state is another potential problem. In its report, the NQF says states should institute policies that permit facilities to report an event only once to a single state entity.

Other relevant state-based reporting systems, such as state health care licensing entities, should retrieve reports from the primary receiving entity, not through a duplicate report from the facility. If this is not done, the NQF says, states should, at minimum, enact policies that allow the same data in the same form to be filed with multiple agencies.

There will be some delay before states adopt the NQF list, and some problems won’t be fully understood until then. But peer review professionals should use the interim to study the NQF list, Schyve says, and anticipate how reporting those items to the state would affect them.

"Look at the list and use it as a checklist for yourself," he says. "Have you already considered all of these events as sentinel events and responded accordingly, regardless of whether you reported them? Consider how you would want that data reported to the state and influence the way the list is adopted in your state."