On March 5, 2019, the Centers for Medicare & Medicaid Services (CMS) revised Appendix Q to the State Operations Manual, which provides guidance for CMS surveyors in identifying situations of “immediate jeopardy.” Immediate jeopardy arises in situations where recipients of care have suffered or are likely to suffer serious injury, harm, impairment or death as a result of provider, laboratory or supplier noncompliance with health and safety requirements.

The revised Appendix Q to the State Operations Manual (also referred to as Core Appendix Q) includes the following key changes:

1. Core Appendix Q clarifies that a finding of immediate jeopardy involves a determination that (a) noncompliance (b) caused or created a likelihood that serious injury, harm, impairment or death to a recipient would occur or recur, and (c) immediate action is necessary to prevent such injury, harm, impairment or death. Previous guidance indicated that a potential for serious harm may constitute immediate jeopardy. Current guidance states that, in order to cite immediate jeopardy when a recipient of care has not already suffered injury, the noncompliance must create a likelihood that such harm will occur. Also previously, culpability was a required component of immediate jeopardy. CMS removed this as a requirement and replaced it with the key component of noncompliance.

2. Core Appendix Q also includes a section that instructs surveyors to consider whether noncompliance caused or made likely serious mental or psychosocial harm to patients. Surveyors must use the “reasonable person concept” for this determination, which considers whether a reasonable person in a similar situation could be expected to experience serious psychosocial harm from the noncompliance.

3. Surveyors of all provider and supplier types and laboratories will use Core Appendix Q. CMS developed an administrative tool to help surveyors focus on evidence required to find immediate jeopardy. This tool considers the following points:

  1. Whether the entity failed to meet health, safety or quality regulations
  2. If there is sufficient evidence that a serious adverse outcome occurred or is likely to occur
  3. Whether the entity should take immediate action to correct the noncompliance

4. Core Appendix Q makes it clear that immediate jeopardy citations must be independently decided. There are no automatic immediate jeopardy citations.

5. CMS also drafted subparts to Core Appendix Q that focus on immediate jeopardy concerns that occur within nursing homes and clinical laboratories. For example, residents in nursing homes may have particular vulnerabilities that make them more susceptible to harm. Surveyors need to consider these individual vulnerabilities while determining if noncompliance causes serious injury, harm or death.