The United States Department of Health and Human Services Office of Inspector General (HHS OIG) recently released Adverse Events Toolkits: Medical Record Review Methodology and Clinical Guidance for Identifying Harm. HHS OIG released these two toolkits to help the health care community, government agencies, and researchers to identify and measure adverse events in hospitals or other inpatient settings. Adverse events are patient harm events that happen as a result of medical care (or lack of care), not by underlying disease. The toolkits were created based on OIG expertise that was acquired through seven medical record reviews over the course of 15 years.
OIG created the adverse event toolkits to “advance patient safety both through a discussion of methodological considerations when designing studies about patient harm and by providing specific clinical guidance to facilitate medical record reviews.” OIG recognized that hospitals and researchers are unlikely to adopt the medical record review process in its entirety, but that if they adapt OIG’s methods and guidance to identify and track harm events in the facility, it will be beneficial.
Each toolkit has two documents: a summary of HHS OIG’s methodological approach to identify and categorize patient harm and a set of clinical guidance used to decide whether events should be considered patient harm. HHS OIG recommends the tools be used in tandem with one another and they may be adapted in whole or in part.
The toolkits are not meant to be used to determine compliance with any laws, regulations, or other guidance. Instead, they are resources available to help users to develop or update their own medical record review procedures.
Medical Record Review Methodology Toolkit
The Medical Record Review Methodology toolkit includes details about OIG’s definition of patient harm and how the agency categorizes events by severity and preventability. It also includes tips on how to overcome common challenges (including complex cases) and quality assurance.
The goal of OIG’s medical record reviews was to establish a national, point-in-time rate of patient harm. In the toolkit, OIG explained the suggested order of review for a medical record review as well as outlined considerations for reviewing medical records, including the definition of patient harm, the severity of the harm, and the preventability of the harm.
The toolkit also includes two appendices: (A) IHI Methodology for Identifying Harm and (B) Contributing Factors for Preventability.
Clinical Guidance for Identifying Harm Toolkit
The Clinical Guidance for Identifying Harm toolkit is a collection of guidance that has been developed or adopted by HHS OIG for assessing care associated with nearly 30 conditions and injuries, including abnormal electrolytes, sepsis, and stroke. Under each condition, OIG discusses how it was determined whether the condition was the result of harm and whether it could have been prevented. This toolkit also includes information about the hospital trigger tool that reviewers used to screen for adverse events and suggestions for finding and recording key information.
In addition to definitions, harm determinations, and preventability information for the conditions, this toolkit also includes hospital trigger tools, such as care module triggers, medication module triggers, surgical module triggers, and intensive care module triggers.
This toolkit includes a handful of worksheets in the appendix, including trigger tool worksheets for: hospitals, skilled nursing facilities, inpatient rehabilitation facilities, long-term care hospitals, and Indian health service hospitals.