What the Navigator includes

The primary focus of the Betsy Lehman Center’s Patient Safety Navigator is to help Massachusetts health care facilities, programs, and professionals identify regulatory reporting requirements related to dozens of known adverse patient safety events. Examples include serious reportable events (SREs) and serious incidents to the Massachusetts Department of Public Health, and reports of device-related adverse events to the U.S. Food and Drug Administration. The Navigator also describes, in less detail, how to report other events that can affect the safety of patients, such as drug diversions or professional disciplinary actions. Obligations associated with health care licenses form the basis for most of the requirements outlined in this tool.

In addition, the Navigator offers important resources providers can use in the wake of a serious patient safety event, including tools for conducting a thorough root cause analysis and for communicating about adverse events both with staff and to patients and families.


What the Navigator does not include

1. This tool does not include a mechanism for collecting reports of patient safety events from providers. It guides users to information about how to file reports with various other agencies using existing systems at those agencies.

2. The Navigator does not identify all reporting obligations that potentially relate to patient safety. Importantly, it does not identify requirements imposed by the Centers for Medicare & Medicaid Services (CMS), including those tied to a quality reporting program (e.g. the Hospital Inpatient Quality Reporting). Examples of other reporting requirements that the Navigator specifically does not cover include:

  • Requirements imposed by:
    • Accrediting agencies or professional societies
    • MassHealth
    • Other states (if applicable);
  • Quality reporting requirements (including any requirement to include an adverse event in a quality report or other routine report);
  • Internal reporting procedures (including any legal requirements to follow particular internal reporting procedures or to record the event in the patient’s medical record) ;
  • Adverse reporting requirements related to clinical research
  • Contractual obligations (including those to health plans).

3. Reporting requirements for some health care entities and professionals operating in Massachusetts do not currently appear in the Navigator. Examples include, but are not limited to, rehabilitation facilities, blood banks, and intermediate care facilities for individuals with intellectual disabilities. These entities were excluded because of their minimal adverse event reporting obligations, or similar reasons.

4. None of the content and resources developed for this site should be considered regulatory guidance or legal advice. The Betsy Lehman Center is not a regulatory agency, and the information contained in the Navigator does not have the authority of a regulatory guidance document.

5. Requirements specific to government-operated facilities (e.g. public health hospitals) are generally outside the scope of the Navigator, even though the facilities may be subject to all or some of the same reporting obligations.

Summary

The Navigator is not intended to exhaustively and comprehensively address all reporting requirements.

This tool aims to help providers identify key patient safety reporting obligations that will likely arise when patient safety is compromised or at risk. It is not possible for this online tool to anticipate every scenario or situation that may arise. As a result, do not rely solely on the Navigator to identify all possible reporting requirements. When in doubt, contact the relevant licensing, accrediting, or other authority.

For more information, see the Terms of Use.