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Revisions to immediate jeopardy process spotlights accountability of facility


May 1, 2019

Be prepared to be held accountable for actions by contractors, staff, or volunteers that result in noncompliance with CMS Conditions of Participation (CoP). If those actions put a patient in harm’s way, your facility could face a finding of immediate jeopardy.

In an effort to streamline its process and increase communication with providers, CMS has rewritten its guidance for surveyors on when and how to determine if an immediate jeopardy (IJ) to patients exists. An unresolved IJ finding can threaten your ability to bill Medicare.

There are now three key components that must be met for immediate jeopardy to be called:

  1. Noncompliance with a single federal safety standard
  2. Evidence of harm or likelihood of harm
  3. The determination that there is an immediate need for action to prevent harm, or more harm, from occurring.

In addition, before they leave the premises surveyors must also present a form listing the evidence for each component of the IJ decision. The revisions apply to all provider types.

The revisions were outlined in a memo to CMS state survey agencies from the Quality, Safety & Oversight (QSO) group. In QSO-19-09-ALL, “Revisions to Appendix Q, Guidance on Immediate Jeopardy,” issued March 5, 2019, CMS presented what it hopes is a more efficient process.

Compliance experts hailed the changes that put more emphasis on cause-and-effect in associating noncompliance with CoPs with patient harm.

However, the policy also explicitly says hospitals and other facilities can be held accountable for a staffer’s actions, warns Ernest E. Allen, ARM, CSP, CPHRM, CHFM, a patient safety account executive with The Doctors Company in Columbus, Ohio.

For example, a doctor in a Columbus hospital is being investigated for possibly ordering overdoses of opioids to near-death patients, more than two dozen of whom died, according to media reports. The doctor was fired in January and had his medical license suspended, pending investigation, while more than 20 nurses and pharmacists were put on leave. In February, CMS declared an immediate jeopardy situation at the hospital, accepted a plan of correction, and removed the IJ after later inspections.

“In my opinion, this new policy takes that [kind of situation] into consideration,” says Allen, noting the section of the revised guidance:

“Please note, in determining noncompliance an entity may state that they properly trained and supervised individuals and that it was a ‘rogue’ employee that violated a regulation. If this occurs, it should be cited as noncompliance despite an entity’s compliance efforts to train and monitor the employee. An entity cannot disown the acts of its employees, operators, consultants, contractors, or volunteers or disassociate itself from the consequences of their actions to avoid a finding of noncompliance,” states the revised guidance.

Revisions create core guidance

The new process is effective immediately. Surveyors were given until March 22 to complete the online training on the process. 

The original 34-page Appendix Q, written in 2004, relied heavily on examples taken from nursing homes and other long-term care facilities.

The appendix now is broken out into a 12-page Core Appendix Q, plus subparts to address unique conditions found in long-term care facilities (nursing and skilled nursing facilities) and laboratories that operate under regulations set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

By breaking out those subparts and creating the mandatory two-page IJ template, CMS is telling surveyors it hopes the revisions can help them do a better job of determining immediate jeopardy and communicating problems to healthcare providers so they can “more quickly address and correct identified concerns.”

Some changes welcome

Among major revisions, surveyors will no longer determine if culpability was involved. Also, there must be a clear cause-and-effect relationship between the noncompliance and the serious harm or likelihood of harm. CMS is telling surveyors, “to determine that IJ exists, it’s not sufficient to simply say, ‘Here’s some harm that has occurred and here’s some noncompliance’,” according to online training CMS published along with a memo outlining the changes.

It’s a key change that will be welcome, particularly by hospitals, notes Jennifer Cowel, RN, MHSA, CEO of Patton Healthcare Consulting and a former director of service operations for The Joint Commission (TJC).

 “The revisions clearly state that you cannot call IJ simply because there is a potential for serious harm,” she says. “Now, under the revised guidelines there has to be a likelihood for serious adverse outcome as a result of the situation. A reasonable person has to determine a serious event is a likelihood.  We have seen IJ called when it was a mere ‘potential’ for harm, but harm may not have been a likelihood.”

The revisions include definitions of key terms, including likely or likelihood of harm: “Likely/Likelihood means the nature and/or extent of the identified noncompliance creates a reasonable expectation that an adverse outcome resulting in serious injury, harm, impairment, or death will occur if not corrected.”

‘Reasonable person’ concept in use

However, what constitutes “reasonable expectation” is not defined in revised appendix. In the online training, CMS acknowledges that while applying the “reasonable person” concept to determining harm has been around for a long time in long-term care settings, it is a significant change in IJ guidance for other provider types.

The training says the concept is particularly necessary when noncompliance with a standard results in no physical harm, such as injury or death, but surveyors determine an immediate jeopardy situation exists for psychosocial harm on a recipient of care after applying the “reasonable person” concept.

“The reasonable person approach considers how a reasonable person in the recipient’s position would be impacted by the noncompliance,” according to CMS.

“When they clarify that ‘likelihood’ is synonymous with reasonable expectation, it still distances itself from calling an IJ just for a remote possibility of harm,” says Cowel, noting that the memo includes an expectation that state surveyors will participate in online education.

CMS’ revisions “challenge the surveyor,” says Cowel, “and state the surveyor must reasonably expect a specific serious adverse outcome is likely to occur if immediate action is not taken.” 

Impact unclear

While the revisions may offer a clearer understanding of the process, consultants say, it doesn’t necessarily mean anything will be easier or more difficult for providers. And it’s unclear yet how the revisions will impact how or how often accrediting organizations will determine immediate jeopardy.

The terms are clearer, but the reality is IJs occur infrequently in hospitals, notes Kurt Patton, MS, RPh, former director of accreditation services for The Joint Commission (TJC) and founder of Patton Healthcare Consulting, in Naperville, Illinois.

TJC now is focused primarily on infection control (IC) issues when determining a preliminary denial of accreditation, TJC’s version of immediate jeopardy. CMS focuses more on patient’s rights issues, including restraint and seclusion problems or patient grievances, says Patton.

It is with such adverse events Patton predicts that the discussion of “psychosocial harm” will come into play. “I would anticipate this being associated only with improper restraint and seclusion or direct abuse by staff, not the usual medical incidents,” he says.

Determining such harm could prove problematic for providers, says Allen.

“I think this will make things harder and more strict regarding deficiency findings on CMS and Joint Commission surveys,” says Allen. “The new ‘psychosocial harm’ in my opinion is surveyor dependent and hard for a hospital to dispute.”

‘Psychosocial harm’ a factor

The CMS surveyor training notes that psychosocial harm can particularly apply to patients with impaired cognitive function: “Suppose someone is the victim of sexual exploitation: naked pictures were taken of this individual, but due to cognitive impairment, the person was unable to appreciate the gravity of the harm done. If we apply the ‘reasonable person’ concept, we’re likely to determine that a reasonable person would be mortified to be disrobed and exploited in that way. We can then more accurately gauge the seriousness of the psychosocial harm this person suffered.”

CMS emphasizes in the memo introducing the revisions that the term “culpability” has been removed from the IJ equation.

“The previous version of Appendix Q made culpability a required component to cite immediate jeopardy. Because the regulatory definitions of immediate jeopardy do not require a finding of culpability, that requirement has been removed and has been replaced with the key component of noncompliance, since the definitions of immediate jeopardy require noncompliance to be the cause of the serious injury, harm, impairment or death, or the likelihood thereof.”

Providers are likely to welcome the change.

“That term was unusual as it requires blameworthiness,” says Patton. “In reality in your hospital, if a patient is injured due to noncompliance, blameworthiness of the organization is immaterial.

Blameworthiness is more pertinent in analyzing staff behaviors associated with an adverse event. Did they follow policy, did the system lead them to the error or did they recklessly disregard safety policies?”
“Blameworthiness is meaningful for the individual, not so for the organization,” he says.



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