Revised Safety Guidance Affects All Healthcare Providers
CMS clarifies immediate jeopardy, creates surveyor tool, and offers public online training.
Revisions to the State Operations Manual (SOM 100-07), Appendix Q, are intended to help federal and state inspectors quickly identify violations of health and safety regulations. In a March 5 blog, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma said new guidance was needed to to make across-the-board improvements in healthcare safety and quality.
“Despite stringent safeguards, alarming stories continue to be reported about people, including some of our most vulnerable individuals, who have experienced harm in healthcare settings that is devastating to these patients and their families. These include cases of sexual, physical, or mental abuse; neglect and medical mistakes resulting in death; and serious and life-threatening injuries or impairments,” Seema said.
The new guidance directly addresses violations of health and safety regulations that put patients in immediate jeopardy. CMS also has drafted subparts to Appendix Q that focus on immediate jeopardy concerns occurring in nursing homes and clinical laboratories.
Among the Revisions
Core Appendix Q contains a number of key changes from the previous version, including:
- Likelihood instead of potential – The previous version of Appendix Q suggested that a potential for serious harm might constitute immediate jeopardy. Core Appendix Q makes it clear that to cite immediate jeopardy in situations where recipients have not already suffered serious injury, harm, impairment or death, the nature and/or extent of the identified noncompliance creates a likelihood (reasonable expectation) that such harm will occur if not corrected, not simply the potential for that level of harm to occur.
- Culpability has been removed – 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.
- Consider Psychosocial harm – Core Appendix Q includes a section instructing surveyors to consider whether noncompliance has caused or made likely serious mental or psychosocial harm to recipients. In situations where the psychosocial outcome to the recipient may be difficult to determine or incongruent with what would be expected, the guidance instructs surveyors to use the reasonable person concept to make that determination. This approach considers how a reasonable person in the recipient’s position would be impacted by the noncompliance (i.e. consider if a reasonable person in a similar situation could be expected to experience a serious psychosocial adverse outcome as a result of the same noncompliance).
- No automatic immediate jeopardy citations – Core Appendix Q makes it clear that each immediate jeopardy citation must be decided independently and there are no automatic immediate jeopardy citations.
Identifying Immediate Jeopardy
To cite immediate jeopardy, inspectors must be able to determine that:
(2.) caused or created a likelihood that serious injury, harm, impairment or death to one or more recipients would occur or recur; and
(3.) immediate action is necessary to prevent the occurrence or recurrence of serious injury, harm, impairment, or death to one or more recipients.
“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,” CMS clarifies in the new guidance.
CMS has also developed an administrative tool (template) for inspectors to use to make sure they have the evidence needed to meet the criteria for immediate jeopardy. Inspectors will use this tool to clearly convey an immediate jeopardy situation to the healthcare provider, supplier, or laboratory.
Online Training for Healthcare Providers
Violations of health and safety regulations carry serious penalties for Medicare- and Medicaid-certified healthcare providers, suppliers, and laboratories. Noncompliance includes the lack of or inadequate emergency preparation. CMS is providing online training on the new guidance to help providers understand the purpose and process of survey and certification. Regional Office and State Survey Agency surveyors, members of management, and training coordinators were required to take this training by March 22.
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