Improving Patient Safety Nationwide through PSOs

Designated a Patient Safety Organization (PSO) by the U.S. Department of Health and Human Services since 2008, the ECRI and the ISMP PSO helps drive improvements in patient safety by working with organizations and stakeholders across all settings of care.

ECRI Responds to OIG Report on PSOs, Sharing Additional Strategies to Improve Impact of PSOs Nationwide

The HHS Office of Inspector General (OIG) published a report on September 16, 2025, “The Patient Safety Organization Program: Key Barriers Impeding Nationwide Progress Toward Reducing Patient Harm in Hospitals.” The report concluded that although PSOs have helped some hospitals and health systems improve, OIG identified key challenges that hold the program back from achieving progress nationally, including limited alignment with other patient safety efforts; uncertainty about legal protections for hospitals that work with PSOs; lack of patient and family involvement; and missed opportunities to leverage newer technologies.

ECRI responded to OIG and HHS with this letter, which supported the report’s recommendations, offering up ECRI’s insights and additional strategies to advance the progress of PSOs nationally.

Learn more in this Q&A with ECRI’s Patient Safety Leader

Shannon Davila, MSN, RN, CPPS, CPHQ, CIC, FAPIC
Leader of the ECRI and ISMP PSO and Executive Director of ECRI Total Systems Safety

What does the ECRI and ISMP PSO do?

ECRI’s safety, risk, quality, medication safety, infection prevention, and device experts work together to help PSO members improve safety. Through a national learning system, we support healthcare safety staff with data-driven insights and time-saving resources so they can focus on reducing risk in care delivery. Our patient safety team studies events, identifies contributing factors, and researches best practices for safety. We provide PSO members risk assessments to pinpoint gaps and opportunities; education about risks and compliance; and causal analysis review to get to the source of problems. We assign every PSO member a dedicated PSO advisor to act as a safety coach to help address challenges quickly. Our advisors provide access to our breadth of expertise – from infection prevention to medication safety and more. The analysts are highly experienced nurses, clinicians, risk managers, safety leaders, and pharmacists.

With over 100 PSOs in the U.S., how does the ECRI and ISMP PSO compare to others in the nation?

ECRI is one of the largest patient safety entities in the world, and our PSO is among the nation’s largest. The ECRI and ISMP PSO has gathered and analyzes one of the largest datasets of its kind in the industry, with more than 8 million safety events submitted by acute, non-acute, ambulatory, and aging healthcare providers nationwide; plus over 6,000 root cause analyses (RCAs).

ECRI is also the only organization designed as both an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and a federally certified Patient Safety Organization by HHS.

We’re also the only PSO that incorporates the gold standard of medication safety expertise through the Institute for Medication Safety Practices (ISMP). ISMP brings extensive experience in determining the system-based causes of medication errors and driving change in medical practice and pharmaceutical products.

Holistically, these services really move the needle for our PSO member institutions – like our Midwest health system that successfully reduced CAUTI incidences; and another large health system that improved safety culture and reduced patient harm.

Why do you think we still see high rates of preventable harm and safety events in healthcare, despite the work of PSOs across the U.S.?

That’s a complicated question and an issue we have sounded the alarm about at ECRI for many years. Despite the efforts of so many dedicated leaders and frontline staff, we struggle to make and sustain progress nationwide. I attribute that to a number of factors.

Healthcare is becoming vastly more complex – from the increasing prevalence of chronic and comorbid conditions, to advanced medtech and devices, to expanding pharmaceuticals and treatment options. Clinicians are navigating complex transitions of care across multiple providers and settings, barriers in electronic health records and digital tools, and the proliferation of telehealth, virtual care and hospital-at-home. At the same time, resource constraints, staffing shortages and clinician burnout have undermined the sustainability of safety improvements. As a result, preventable errors, like medication mistakes, diagnostic delays, and hospital-acquired infections, continue to occur at unacceptably high rates, reflecting a systemic failure to translate well-intentioned reforms into lasting change.

Every year we identify the top safety concerns and hazards impacting care delivery, and strategies to mitigate risk in our Top Ten Patient Safety Concerns and our Top Ten Health Technology Hazards. These resources guide PSO clients and the industry at-large in navigating a broad range of challenges from cybersecurity breaches of patient data, to counterfeit drugs, to insufficient governance of AI applications.

So, the obstacles we face as an industry are vast, but we are hopeful about the progress we can make nationwide by taking a more systematic approach to care delivery – one that factors in best practices from other high-risk industries like smart system design, human factors engineering, safety culture, and true standardization in clinical operating systems.

One significant obstacle we face in national efforts to improve patient safety is the lack of a consistent measurement tool for tracking harm rates nationwide. Patient harm definitions vary widely, making it difficult to aggregate events and analyze nationwide trends. We need to use shared language and taxonomy, consistently.

In this and other challenges, there are certainly strategies we can execute as PSOs to lead the charge – including some of the recommendations recently pointed out by AHRQ and OIG in the PSO Report.

How does ECRI address the areas of concern noted in the OIG report?

The report highlights several ways PSOs nationwide can improve. Those areas number among the greatest strengths and differentiators of our ECRI and ISMP PSO – particularly our alignment with other patient safety efforts and research; and our emphasis on patient and family involvement in quality, safe care.

ECRI’s Alignment with Other Patient Safety Efforts & Research

• The ECRI and ISMP PSO is the only PSO in the U.S. that’s also an Evidence-Based Practice Center (EPC). Through the ECRI-Penn Medicine EPC, we’ve delivered critical insights focused on improving patient safety including seven rapid evidence reports for AHRQ’s Making Healthcare Safer IV series. One of these reports, Engaging Family Caregivers With Structured Communication for Safe Care Transitions, highlights the need for further research in this space.
• ECRI serves on the National Steering Committee for Patient Safety and participated in activities that led to the implementation of the National Action Plan, which led to adoption of the CMS Patient Safety Structural Measure in 2024.
• The ECRI and ISMP Patient Safety Organization (PSO) leads numerous research deep-dives, “Safety Sprints,” and collaboratives each year in partnership with other PSOs and national safety organizations. These initiatives analyze PSO data to identify emerging safety threats and trends. They leverage actionable toolkits, curated resources, and data-driven, evidence-based best practices to support rapid improvement and meaningful change. Recent examples include data analysis of causes of maternal safety events, and contributing factors in diagnostic errors.
• In 2026, the ECRI and ISMP PSO will host a Safety Sprint focused on mental health and suicide prevention, leveraging insights from its national PSO event dataset and RCA database.
• Additionally, in 2026 ECRI will launch a national learning collaborative aimed at preventing device-related infections, bringing together healthcare organizations to share strategies, data, and evidence-based practices for reducing harm.

ECRI’s Emphasis on Patient and Family Involvement

• ECRI has hosted several annual collaboratives focused on activating patients and caregivers as partners in safety, in collaboration with national patient advocacy organizations. In 2025, ECRI facilitated a learning collaborative on “Activating Patients as Partners,” designed to support the CMS Patient Safety Structural Measure. Over five months, participants worked under the protections of the Patient Safety and Quality Improvement Act (PSQIA), engaging with subject matter experts and peer organizations to identify and apply critical strategies for meaningful patient partnership in safety initiatives.
• The ECRI and ISMP PSO is one of only a couple PSOs in the nation (out of 100+) that’s a strategic partner with Patients for Patient Safety (PFPS) in Project PIVOT, a patient-led initiative that integrates patient-reported experiences (PREs) and outcomes (PROs) to improve patient safety, diagnostic accuracy, and health equity.
• ECRI has long called out patient engagement as critical to safe, quality care, including through the annual Top Ten Patient Safety Concerns, research reports generated with input from patient advocacy groups such as PFPS. These reports have consistently highlighted the need for strong patient and family involvement, most recently in the #1 safety concern for 2025: “dismissing patient and caregiver concerns.” ECRI provided strategies to improve patient engagement through several frameworks: culture, leadership, governance, and an agile learning system.

Learn more about the ECRI and ISMP PSO.

Contact: Yvonne Rhodes, Director of Strategic Communications & Operations, YRhodes@ECRI.org