Strengthening Accountability in Hospital Reporting of Patient Harm Events

Today, I want to bring attention to an issue that is once again under scrutiny, how hospitals report patient harm events under the Centers for Medicare & Medicaid Services (CMS) and state requirements.

The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) has announced a new review as part of its January 2025 Workplan, aiming to determine whether hospitals are accurately reporting these events in compliance with federal and state regulations.

Hospitals are required to collect, track, and analyze patient harm events to improve quality of care and meet regulatory requirements. These events include adverse drug reactions, surgical errors, infections, and falls, among others.

Some events, classified as “never events” or sentinel events, are so serious that CMS and state agencies mandate their reporting.  This issue isn’t new. As a young health information management (HIM) professional (roughly 30 years ago), part of my duties were to review the sentinel events and send those to the executive leadership of the hospital for follow-up action. 

However, the OIG past investigations have painted a concerning picture. In a prior study, the OIG found that hospitals reported only a small fraction of adverse events to state reporting systems. The 2018 OIG report Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm revealed that 25 percent of Medicare patients suffered harm in just one month. Some of these incidents were avoidable, yet hospitals largely failed to report them to the appropriate oversight agencies.

This raises important questions, including the following:

• Why are hospitals underreporting patient harm events?
• Are reporting systems too complex, or is there reluctance due to potential repercussions?
• How can we ensure transparency while also fostering a culture of patient safety and accountability?

The 2025 OIG study (OEI-06-18-00401) will build on prior research by comparing what hospitals actually report versus what a medical review identifies as harm events. This approach will help uncover whether hospitals are truly fulfilling their obligations or whether underreporting remains a systemic problem.

The implications of this review extend beyond just compliance. Failure to report harm events has real-world consequences:

1. Patients remain at risk – Unreported events mean hospitals miss opportunities to improve care, potentially leading to repeat errors that harm future patients.
2. Hospitals face regulatory and financial risks – Underreporting may lead to CMS audits, penalties, and even loss of accreditation in severe cases.
3. Trust in the healthcare system erodes – When harm events are not disclosed, patients, families, and policymakers lose confidence in hospital transparency and patient safety efforts.

With this increased scrutiny from OIG, hospitals must proactively strengthen their harm event reporting processes. Here’s how:

• Improve internal reporting mechanisms – Implement real-time tracking tools that capture harm events as they happen.
• Empower frontline staff – Train clinicians and hospital personnel on the importance of accurate harm event reporting and ensure they understand state and CMS requirements.
• Utilize AI-driven solutions – Advanced AI and clinical decision support tools can help detect patterns of harm events, improving early identification and reporting compliance.
• Foster a culture of transparency – Reporting patient harm should not be seen as punitive. Instead, hospitals should adopt a learning mindset, using reported data to drive continuous improvement.

This upcoming OIG report will be a defining moment for hospital accountability. If it confirms that underreporting remains widespread, we could see stronger regulatory enforcement, increased penalties, and more rigorous oversight.

Now is the time for hospitals to reassess their internal policies, strengthen their reporting culture, and ensure that patient safety remains the top priority.

Because at the end of the day, transparency in harm event reporting isn’t just about compliance it’s about protecting lives.

Programming note:

Listen to Angela Comfort Tuesdays when she cohosts Talk Ten Tuesday with Chuck Buck at 10 Eastern.