Protecting the Health and Safety of all Americans

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.

Seeking medical or long-term care is a critical decision many people will face at some point in their lives. Whether the care is for personal reasons or for a loved one, quality and safety are factors that cannot be compromised.

There is absolutely no room in America’s healthcare system for any situation that violates quality or safety standards. That’s why CMS is issuing new guidance that takes a key step towards making across-the-board improvements in healthcare safety and quality.

This guidance directly addresses violations of health and safety regulations that cause serious harm or death to a patient and require immediate action to prevent further serious harm.  These situations are called immediate jeopardy. It’s critical that federal and state inspectors accurately identify, thoroughly investigate, and ensure immediate jeopardy situations are resolved decisively and swiftly. These egregious violations carry the most serious penalties for Medicare- and Medicaid-certified healthcare providers, suppliers, and laboratories. CMS provides inspectors guidance on quickly identifying and handling these urgent situations, but many stakeholders have voiced concerns that the guidance needs to be clearer and more consistent to identify serious quality concerns across states.

CMS is acting on that feedback, and this new guidance clarifies what information is needed to identify immediate jeopardy cases across all healthcare provider types, which we believe will result in quickly identifying and ultimately preventing these situations. This new guidance can be found in Appendix Q of the State Operations Manual that federal and state inspectors use.

In addition to the guidance, we’ve also developed an administrative tool that helps inspectors make sure they have the evidence needed to meet criteria for immediate jeopardy. Inspectors will use this tool to clearly convey the immediate jeopardy situation to the healthcare provider, supplier, or laboratory, so facilities can take preventive action quickly against further harm.

Because these changes affect all Medicare- and Medicaid-certified healthcare providers, suppliers, and laboratories, CMS is providing online training on this new guidance, available to the public at  https://surveyortraining.cms.hhs.gov/.

The revised guidance and administrative tools can be found at http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html, and will be uploaded to the online State Operations Manual within a few weeks.

Investigators will now have a clear framework to identify serious patient health and safety problems. Today’s guidance is just the beginning of upcoming efforts to strengthen oversight of healthcare settings. Expect to hear more from us on this issue. This is part of the agency’s broader initiative of ensuring safety and quality, and we look forward to continuing to work on this priority across all our programs.