Trust, Legal Protection Place Value in Patient Safety Organizations

Patient safety organizations (PSOs) are crucial for both patients and pharmacists in ensuring safe and effective distribution of medications, health care technology, and general medical services. However, PSOs rely significantly on creating an environment of confidentiality and trust where providers and health care leaders are not reprimanded for the potential errors they can make in their operations.

“The reason that it has to be legally protected is these providers don't want to be subject to any kind of punitive damages from lawsuits,” Catie Stimmel, PharmD, vice president and chief controlled substance and patient safety officer at Walgreens, told Drug Topics. “They don't want to be sanctioned by providers or regulators. This allows that safety net of trust, where they know that their data is going to be confidential and anonymized.”

The true value in PSOs exists in their work to create an ecosystem of education and data to inform future health care interactions. Relating back to clichéd sentiments of having to fail in order to succeed, PSO functions are similar in that they are reliant on documenting mistakes and errors to inform future actions.

In part 2 of our interview with Stimmel, she dives deep into the importance of PSOs existing in a non-punitive space. Get expert insights on PSOs and learn more about why they are crucial stakeholders within the health care community.

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Drug Topics: When it comes to the value that PSO’s provide, why is it important for the spaces surrounding them to be non-punitive and protected for patients?

Catie Stimmel: That is a really important thing: to build trust. Before the Patient Safety and Quality Improvement Act (PSQIA) erected PSOs and allowed for PSOs to have this legally protected space, sometimes providers wouldn't always report errors. They certainly wouldn't volunteer that information. What happens when you don't talk about errors, when you're not discussing it, and when you're not learning from it, is that you can't move the system forward. You can't improve the processes; you can't improve the technology. They really only work when you report honestly and early. If our clinicians are going to fear punitive responses from reporting, that's going to break that safety net of trust.

What this allows is for a system of reporting where providers can tell us about the safety concerns they have, share their experiences, and then we can all work together to improve the overall delivery of health care. The reason that it has to be legally protected is these providers don't want to be subject to any kind of punitive damages from lawsuits. They don't want to be sanctioned by providers or regulators. This allows that safety net of trust, where they know that their data is going to be confidential and anonymized, and that we can use that data to then learn and prevent errors from happening in the future. Really, it’s for the pharmacist to help them provide at the top of their game, and it's also for the patients to keep them safe.

Drug Topics: What is the current state of the regulatory framework surrounding PSOs in the US and how is that framework creating uncertainty among PSO operations?

Catie Stimmel: I think it's really just about the clarity of the regulations and more education. The current regulatory frameworks around PSOs involve the PSQIA and the Patient Safety Rule. They create that federal confidentiality and privilege framework with the Agency of Healthcare Research and Quality, maintaining that PSO listing and program guidance. If the PSO protections aren't respected or maybe overruled by individuals who don't really understand the intent of the legislation, or how the legislation plays out in operations, we could risk returning to an era of under reporting. That risk can actually impair our learning system or even destroy the very learning system that is helping PSOs improve patient safety in the nation.

The framework was really created to provide stability and certainty, but it does leave uncertainty in practical application, particularly surrounding that legal discovery—what can be reported, what can't be reported, and what reporting expectations are. New interpretations of the statute can really create complexity and actually impede that improvement that we're looking to make in health care.

READ MORE: Public Health Resource Center

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