Sentinel event RCAs don’t always lead to on-site review; reporting rules eased

Accreditation watch reserved only for uncooperative providers

Even though sentinel events and the resulting root cause analyses continue to strike fear in the hearts of risk managers, the good news from the Joint Commission on Accreditation of Healthcare Organizations is that most providers reporting their problems do not undergo an on-site review and only the uncooperative providers are likely to be put on accreditation watch.

There is still plenty of bite left in the sentinel event policy even as it evolves to accommodate some of the greatest fears of risk managers, but recent changes in the policy and declarations from Joint Commission officials may ease your mind a bit. Unlike when the policy was first put into effect, it now appears that you do not have to turn over a wealth of confidential information — a "malpractice kit for plaintiffs’ attorneys," as some observers note. And you are not likely to suffer the grave indignity of accreditation watch status as long as you are making a good-faith effort to comply with the rules and help Joint Commission officials understand what happened.

That was the message delivered to attendees of the recent meeting of the American Society for Healthcare Risk Management (ASHRM) in San Diego. At one of the most heavily attended meetings, risk managers listened closely, perhaps sometimes skeptically, to what the Joint Commission representative had to say about changes made to the policy only a few days before.

In the latest evolution of the policy, the Joint Commission provided one more option for how it might review a provider’s root cause analysis — the report prepared by the provider after a sentinel event that is intended to ferret out the true, systematic cause of the event and highlight ways to correct the problem. Risk managers have complained that the original policy required them to hand over, in the form of the root cause analysis, a great deal of information that would otherwise be confidential and unavailable to plaintiffs’ attorneys. Previous changes to the policy were intended to address those concerns by providing options that did not involve handing over the root cause analysis.

Now the Joint Commission has added a fourth option with the same intent, says Donna Nowakowski, RN, director of government relations and external affairs for the Joint Commission.

She told ASHRM attendees that the fourth option was made official Oct. 1. A root cause analysis still is required after a sentinel event, but the new fourth option allows the provider to say that hospital officials will discuss policies and procedures and discuss their response to the sentinel event during an on-site visit by Joint Commission investigators but without seeing or even discussing the root cause analysis.

A previous modification allowed the option of discussing the root cause analysis on-site but without allowing it to leave the premises. Providers also can allow investigators to review the root cause analysis on-site, or they can just send it to the Joint Commission. (For the exact wording of the options provided by the Joint Commission, see story, p. 147.)

Accreditation watch not likely

Clearly trying to assuage the fears of risk managers, Nowakowski went on to say that the information in most root cause analyses does not lead the Joint Commission to pursue further on-site evaluation. Many analyses show that the incident in question does not even meet the criteria for a sentinel event, so the Joint Commission just informs the organization of that finding and drops the matter, she says.

She also explained that accreditation watch, the feared end result of a sentinel event investigation, is not likely even when the sentinel event is outrageously bad.

"Accreditation watch is limited to those organizations that don’t share information with the Joint Commission," she says. "It’s possible to put an organization on accreditation watch after giving it a chance to revise an unsatisfactory root cause analysis and still not getting an acceptable result, but in reality, it’s for organizations that just don’t share information."

The statistics provided by Nowakowski support that contention. Between March 1996 and March 1998, 139 providers survived the sentinel event investigation process without being put on accreditation watch. Another 37 organizations were placed on accreditation, and two were put on preliminary nonaccreditation. The numbers since March 1998 are a little different, and Nowakowski suggests that they more accurately reflect the current Joint Commission approach to sentinel events. Since March 1998, 63 organizations were investigated for sentinel events, and only one was placed on accreditation watch.

New option: Don’t reveal root cause analysis

Nowakowski also assured risk managers that a root cause analysis will not have to be divulged during a routine triennial survey by the Joint Commission. Some risk managers have expressed concern that even if the root cause analysis of a sentinel event is not made available during the sentinel event investigation, a Joint Commission surveyor could demand to see all your root cause analyses as part of a routine survey to determine whether you are in compliance. But Nowakowski says the official Joint Commission position is that you do not have to hand over any particular analysis in that circumstance either.

Nowakowski emphasized that the surveyor may ask for all of your root cause analyses, but she says the provider has the right to deny the request and instead provide a sample root cause analysis. The provider is free to choose a root cause analysis that is representative of the way it responds to sentinel events without including sensitive information.

"It’s OK to show a root cause analysis for something like a near suicide or a medication error with no patient harm," she explained. "That shows the Joint Commission your processes without exposing you to liability for disclosing that information."

Differing legal risks from sentinel events

The Joint Commission’s own investigation of how state laws affect the confidentiality of information in a root cause analysis suggests that there is, indeed, a myriad of laws and no easy answer. Legal officials in 44 states replied to the Joint Commission’s survey, with seven indicating that sending a root cause analysis to the Joint Commission surveyors will not jeopardize confidentiality and another seven indicating that surveyor review of the root cause analysis on site, with the surveyor retaining a copy of the analysis, will not jeopardize confidentiality.

Twenty-four of the respondents (55%) said that confidentiality would not be jeopardized if the surveyor reviewed the root cause analysis on site without retaining a copy.

While much of Nowakowski’s comments were greeted with relief from risk managers, a good deal of skepticism remained. Some of that skepticism was expressed by Fay Rozovsky, JD, MPH, DFASHRM, a risk management consultant in Richmond, VA. She also is chair of the ASHRM Sentinel Event Task Force and the ASHRM representative on the Joint Commission-American Hospital Association National Legal Task Force that has been addressing risk managers’ concerns about the sentinel event policy.

Rozovsky says there may be an unofficial fifth option when responding to a sentinel event, beyond the four options involving the root cause analysis.

"The fifth option would be the hospital board respectfully saying, we will not participate because we see no basis for the sentinel event allegation,’" she said. "That probably would lead to accreditation watch and possibly non-accreditation, but I think it has to be considered another option when responding."

Rozovsky also says the new fourth option — discussing policies and procedures with the Joint Commission surveyor without discussing or sharing the root cause analysis — may not work for some providers.

"If the Joint Commission decides what you’ve done is not enough, they can demand a focused review with more documents," she says. "If those documents are the ones you were trying to protect in the first place, you haven’t accomplished anything and you’re paying for the visits."

Concerns remain with sentinel event policy

Though she praised the way the Joint Commission had worked to accommodate the concerns of risk managers, Rozovsky said many problems remained. For instance, she said the 45-day rule for responding with a root cause analysis is too short a time frame if any sort of criminal investigation also is involved.

"You can’t get in the way of forensic evidence, and believe me, if it comes to disappointing the Joint Commission or having the local police charge me with obstructing their investigation, I know what choice I’m making," she says. "In some cases, the constraints of a criminal investigation can even prevent you from getting enough information to make the five-day reporting rule."

Rozovsky also points out that the process of conducting a root cause analysis could result in an emotional distress claim being filed against the provider by an employee. The analysis often requires those involved in the incident to relive it again and again by explaining it and dissecting each little portion. For an especially tragic or scary event, that could traumatize the patient so much that he or she would end up filing an emotional distress claim.

Rozovsky also points out that some medical staff will refuse to participate in the extensive research required for the root cause analysis if your medical staff bylaws do not require them to participate.

She suggests checking your bylaws to see if medical staff would be obligated to participate, and if not, you should change the bylaws. Physicians and nurses usually will be advised to keep their mouths shut about any incident likely to involve a lawsuit, so don’t be surprised if they say the root cause analysis is beyond the clinical investigation to which they feel obligated.

Also, Rozovsky says she fears if an employee feels backed into a corner by the root cause analysis, he or she could respond by filing a qui tam lawsuit to expose some alleged misconduct at the hospital. That is most likely when the analysis seems to be heading in a direction that would single out an individual as the responsible party in the sentinel event, even if the failing ultimately is traced to a systemic shortcoming.

For more information about the Joint Commission’s Sentinel Event Policy and Procedures, visit the Joint Commission’s Web site at jcaho.org or call the Sentinel Event Hot Line at (630) 792-3700.


For More Information

o Donna Nowakowski, Joint Commission on Accreditation of Healthcare Organizations 1 Renaissance Blvd, Oakbrook Terrace, IL 60181. Telephone: (630) 792-5000.

o Fay Rozovsky, 12317 Pleasant Lake Terrace, Richmond, VA 23233. Telephone: (804) 364-2956.