Appendix Q – Core Guidelines for Determining Immediate Jeopardy (Rev. 187, Issued: 03-06-19)
The Centers for Medicare and Medicaid Services (CMS) has issued new guidance clarifying the immediate jeopardy survey and enforcement process. The changes apply to and impact all provider types. Please review and share this new update with peers and colleagues. Of special note – Harm does not have occur; only the likelihood of harm to a patient needs to be present.
- The three (3) requirements that must be answered by the survey team are:
- Non-compliance with a specific regulation or standard in the CoP’s/CfC’s;
- Seriousness which includes likelihood;
- Need for Immediate Action.
- Definitions and Concepts that have been changed, clarified, removed or added:
- Immediate Jeopardy was clarified.
- Need for Immediate Action replaced Immediacy.
- Culpability was removed.
- Reasonable Person concept was added for patients who are not competent/able.
- Removal Plan replaced Plan of Correction.
- Threshold of Seriousness now includes the LIKELIHOOD of harm / Risk of Harm.
- Causation does not have to be proven and Factors do not have to be documented.
- Concepts of Seriousness, Likelihood and Causation have been clarified.
- The categories of harm / likelihood of harm include:
- The survey team MUST complete a preliminary IJ template that includes identification of the specific noncompliance, threshold of seriousness and need for immediate action. This document MUST be left with the provider before the survey team departs.
- A Removal Plan must be developed instead of a Plan of Correction.
- The Survey Team may depart the organization with the Immediate Jeopardy noncompliance still in place – the removal plan must be approved by RO. (A survey team WILL return to survey).
- Immediate Jeopardy can only be removed through an on-site survey where the team validates that the removal plan was fully implemented, and that CMS/RO can be reasonably assured that compliance can be sustained.
- Removal Plans must include:
- How facility will ensure harm will not occur/reoccur;
- Date of implementation – planned implementation (actions do not need fully resolved prior to the survey team exiting the organization);
- Identify those recipients who have suffered, or are likely to suffer, a serious adverse outcome as a result of the noncompliance; and
- Specify the action the entity will take to alter the process or system failure to prevent a serious adverse outcome from occurring or recurring, and when the action will be complete.
The definitions included in the new update are major changes and clarifications. We will discuss this further in an upcoming newsletter and we will have a Removal Plan template available soon.
Find Appendix Q – Immediate Jeopardy at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_q_immedjeopardy.pdf