How to Use the OIG’s New Toolkits on Identifying Patient Harm

Patient safety and quality of care has long been a focus area for many providers and health systems.

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has recently demonstrated more activity in the patient harm or adverse events arena even though historically speaking, the OIG has not been extraordinarily active in this space.

In their most recent report on this topic (https://oig.hhs.gov/oei/reports/OEI-06-18-00400.asp), the OIG identified 25% of Medicare patients experienced patient harm during their hospital stays for their sample. The OIG includes adverse events and temporary harm events in their definition of patient harm.

A closer look at their report revealed that 12% of patients experienced adverse events that led to longer hospital stays, permanent harm, life-saving intervention, or death. In addition to the patients who experienced adverse events, 13% of patients experienced temporary harm events, which required intervention but did not cause lasting harm, prolong hospital stays, or require life-sustaining measures.

They classified the most common type of harm events in the following way:

• Harm events related to medication (43%)
• Events related to patient care (23%), such as pressure injuries
• Procedures and surgeries (22%)
• Infections (11%)

Since the publication of this report, in July 2023, the OIG released two toolkits to assist providers with their efforts in reducing harm events. The two toolkits are:

1. Toolkit: Medical Record Review Methodology https://oig.hhs.gov/oei/reports/OEI-06-21-00030.pdf
2. Toolkit: Clinical Guidance for Identifying Harm https://oig.hhs.gov/oei/reports/OEI-06-21-00031.pdf

Toolkit: Medical Record Review Methodology

This toolkit provides information about how the OIG conducted medical record reviews to identify patient harm and their decision criteria for adverse events. This may be useful to health care providers and researchers dedicated to patient safety.

The OIG’s methods build upon the Global Trigger Tool (GTT) methodology developed by the Institute for Healthcare Improvement (IHI), which they adapted and used for screening and flagging medical records for possible patient harm.

OIG conducted retrospective reviews of medical records to identify harm events using a two-stage process. Sample sizes ranged between 300 and 800, depending on the setting.

The stages are:

1. A manual screening process using a Global Trigger Tool (GTT)
2. A comprehensive physician review

The OIG provides a suggested order of review as it may shorten the review timeframe. The order they suggest is as follows:

1. Diagnosis and procedure codes
2. Discharge summary
3. History and physical
4. Medication administration record
5. Laboratory results and radiology reports
6. Prescriber orders
7. Operative record
8. Daily progress notes
9. Skin/wound assessment
10. Other pertinent records (e.g., contiguous emergency department records)

In addition to their process, the OIG toolkit addresses the following topics as well: definition of patient harm, severity of harm, preventability of harm, complex cases, medical record review protocol, quality assurance, and appendices that include the IHI methodology for identifying harm and contributing factors for preventability.

Toolkit: Clinical Guidance for Identifying Harm

The OIG has provided this toolkit as a resource for details about how clinical experts assessed specific conditions and injuries related to common types of harm events while conducting their medical record reviews. It also includes information about the “triggers” (i.e., clinical clues of harm) their reviewers used to screen for possible harm events in hospitals.

It offers users a section named, “Specific Conditions and Injuries” as guidance on harm identification and categorization for 29 conditions encountered during the OIG medical record reviews. These include conditions and injuries that were commonly found in their reviews and for which OIG provided specific guidance to reviewers. They are quick to point out the list is not comprehensive of all types of patient harm events.

The toolkit also includes the section “Hospital Trigger Tool.” This section contains the triggers the OIG used to flag potential harm events in hospitals. They used triggers like clinical clues within the medical record that may indicate harm (e.g., abnormal laboratory values or falls). An appendix in this resource includes the trigger tool worksheets that reviewers used in different health care settings.

It’s important to note the OIG performed their review on Medicare beneficiaries in the hospital during October of 2018. Thus, the clinical information presented is current as of that time. In publishing their toolkit, they did not reassess all clinical guidelines. For this reason, OIG emphasizes users should seek out the most recent clinical guidance and standards of care and apply those to their adverse event determinations.

Conclusion

These new toolkits by the OIG offer resources providers can use to improve patient safety. Compliance professionals not familiar with clinical harm events might not be comfortable addressing these issues on their own, but they should bring these resources to the attention of those in their organizations who lead out on patient safety initiatives and efforts.

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