JCAHO clarifies sentinel events, compliance
In a candid exchange with risk managers stymied by how to handle the new "sentinel event" policy, a Joint Commission official recently offered clarifications on some of the more perplexing aspects and provided breaking news on how the commission soon might update the policy to make it more strict.
The information was provided by Linda Juhant, assistant director for hospitals and laboratories in the department of education programs of the Joint Commission on the Accreditation of Health Care Organizations in Oakbrook Terrace, IL. Her presentation at the recent meeting of the American Society of Health Care Risk Manage-ment (ASHRM) in Atlanta was heavily attended by risk managers who expressed considerable frustration in understanding the sentinel event policy, along with doubts over how the Joint Commission intends to use it.
With the sentinel event program, the Joint Commission can put facilities on "accreditation watch" status after a particularly egregious error that suggests there may be a systemic problem threatening the health and safety of patients. Once placed on accreditation watch, the facility must present a report on the error, why it happened, and how the systemic error will be corrected. The Joint Commission contends that the program is not punitive but rather a way to ensure that systemic errors are corrected as soon as they are brought to light by an especially bad error. Risk managers, however, have noted that the program can result in a facility losing its license most definitely a punitive action.
The Joint Commission’s vice president for accreditation services, Richard J. Croteau, MD, tells Healthcare Risk Management that the event must be a "serious adverse outcome, such as death, the loss of a limb, loss of function." The adverse outcome must be sufficiently unexpected to suggest that there is an underlying deficiency at the health care facility. He cites an example of amputating the wrong leg.
For clarification, Juhant points to the Joint Commission’s official definition of a sentinel event: "An adverse sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. The event is called sentinel because it sends a signal or sounds a warning that requires immediate attention." Juhant says there are about 10 to 20 sentinel events in each American hospital per year, and most are never reported.
Many sentinel events come to the Joint Commission’s attention through media coverage. Once the facility is placed on accreditation watch, it must submit a report to the Joint Commission within 30 days. The report must include a root cause analysis and a plan for correcting the problems that led to the error. (See form, pp. 8-9.) If necessary, the Joint Commission will provide assistance to the hospital during the investigation. If the initial report is not satisfactory, the Joint Commission will allow another 15 days for a second report. (See story, p. 11, for proposed changes in the sentinel event policy that will make it stricter.)
Update on sentinel events recorded so far
As of October 1997, Juhant says the Joint Commission’s accreditation committee had reviewed 171 sentinel events. Thirty-six involved medication errors, 35 were inpatient suicides, nine were surgery on the wrong side of the patient, 12 involved deaths related to a delay in treatment, nine involved the deaths of patients in restraints, six were transfusion-related deaths, three involved medical gas systems, and two were infant abductions. The other 59 were miscellaneous problems that did not fit into those categories. Of the 171 events, 141 resulted in death. The most common medication error was providing potassium chloride by injection instead of infusion.
One of the most daunting questions regards what exactly constitutes a sentinel event. To help clear up that question, Juhant explains that the event must meet at least two of these criteria:
• It resulted in unanticipated death or major permanent loss of function.
• It is associated with significant deviation from usual process(es).
• It has undermined, or has significant potential for undermining, public confidence.
If the Joint Commission suspects that a sentinel event occurred at your facility, it will follow an established procedure for investigating, Juhant says. First, a Joint Commission official will call the health care provider’s CEO to establish generally what happened.
"We will ask you, Did it really occur as we heard?’" she explains. "We want to make sure that the very basic information we have is correct, that something happened that is at least worth investigating further."
After that, assuming the Joint Commission’s information is not completely off base, Joint Commission investigators will conduct an on-site evaluation. Based on the results of that evaluation, the facility may be placed on accreditation watch. Then the facility must conduct a root cause analysis, after which the accreditation committee can cancel the accreditation watch, change the accreditation status, and/or schedule a six-month follow-up visit.
Definitions provided to help with compliance
The Joint Commission’s policy on sentinel events is carefully worded, but risk managers relate difficulty in applying some of the terms to real-world situations. And without knowing exactly what the commission means in some statements, it is difficult for risk managers to identify sentinel events and then act on them. In response to the pleas of confused risk managers, Juhant provides these official definitions from the Joint Commission:
• Proximate cause: The direct cause of an event, next or nearest to the point of attachment or origin of an event. For a sentinel event, this could be human error or equipment malfunction.
• Systemic cause of failure: A failure that originates at the most basic level of analysis and influences the group of processes that have produced the outcome being studied.
• Common cause variation: Also called endogenous variation or systemic variation, this is an inherent property of all systems produced by interaction of the variables in the system. This type of variation can only be reduced through redesign of the system.
• Special cause variation: Also called exogenous or extrasystemic variation, this is not inherently present in the system itself. It arises from factors that aren’t part of the system as designed. It is intermittent, unpredictable, and unstable.
• Risk point: A specific place in a process or system that is susceptible to error or system breakdown. It usually is a result of a flaw in the design of the process or system, a high degree of dependence on communication, or non- standardization of the process.
The risk managers attending Juhant’s ASHRM presentation had many questions about how best to comply with the sentinel event policy. The following are some of the questions and Juhant’s answers:
o Can "near misses" be sentinel events?
Yes, it is possible for a "near miss" to be a sentinel event even if it did not proceed to an even more serious situation. Juhant provides the example of an infant who is abducted very briefly and recovered before she can be removed from the premises. It is possible that the Joint Commission would consider that a sentinel event if it met two of the three criteria for defining sentinel events. In this example, the incident might meet the last two criteria significant deviation from usual processes and significant potential for undermining public confidence.
o Does the Joint Commission expect facilities to report their own sentinel events?
The Joint Commission is "neutral" on whether you should self-report sentinel events or just wait and see if the commission hears about them. "We neither discourage nor encourage" self-reporting, Juhant says.
o When does the 30-day limit for completing the root cause analysis begin?
You have 30 days from the date you discovered the sentinel event, not necessarily the date it occurred.
o Does the Joint Commission conduct unannounced inspections after sentinel events?
Generally, no. The commission usually notifies you a couple days before its inspectors arrive for the evaluation.
o Is it ever sufficient to say individuals are the root cause of the sentinel event and dismiss, transfer, or retrain them as the solution?
No. The Joint Commission wants to see how the process failed and allowed the individual to make that error. "Thank goodness the FAA [Federal Aviation Administration] doesn’t say that the death of the pilot solves the problem of why the airplane crashed," Juhant explains. "They take a hard look at how the plane crashed, even if it was the pilot’s fault, in hopes of preventing it from happening again."
o Can the root cause analysis be verbal, as opposed to a written document?
No. You must submit a written analysis, which must be sent to the Joint Commission. It is not sufficient to call on the telephone and provide a verbal summary of your written analysis. The commission does not specify what form the root cause analysis must take, but it does provide a sample form to use. "The commission certainly prefers that you use that format," Juhant says.
o Can you call the Joint Commission and ask for an opinion about whether an event is a sentinel event? Would that automatically trigger the sentinel event investigation?
Yes, you can call to get an opinion on whether an event meets the criteria for a sentinel event. That does not automatically trigger an investigation because Joint Commission officials must strongly suspect that the event would meet the criteria.
But you do run the risk of bringing to the Joint Commission’s attention an event it might not have heard about yet. If the event does meet the criteria for a sentinel event, your call could amount to self-reporting, and that is not necessarily a bad thing to do.
o Is the facility charged for being on accreditation watch, or for the evaluation visits?
There is no charge for being on accreditation watch, but the commission does charge for any necessary visits, just as it charges for "for cause" visits. (This confirmation that facilities will be charged for visits was met with murmurs of outrage by the ASHRM meeting attendees.)
o Can’t the "proximate cause" information be used by plaintiffs’ attorneys as an admission of liability or otherwise used against you in a lawsuit?
That is the case in some states. Juhant suggests that you be very careful in how you word that portion of the root cause analysis and get the assistance of legal counsel if you think your state might allow that information to be used against you.
o Is the information from the sentinel event program available to the media and attorneys?
The Joint Commission will release only the accreditation status of the facility and nothing about the information provided as part of the root cause analysis.
But the commission does provide most of that information to the Health Care Financing Administration, where it will be easily accessible when reporters and attorneys realize it is available through that route. ASHRM meeting attendees expressed great concern about the sentinel event policy forcing them to disclose information that attorneys would consider admissions of liability.
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