The Patient Safety Act is part of a larger framework initiated by the Institute of Medicine with 2 primary goals:
- to improve patient safety and reduce medical errors and create a “culture of safety” to disseminate and learn from patient safety events, and
- promote health care providers’ accountability and transparency through oversight by regulatory agencies and adjudication in the legal system. Reporting systems can hold providers accountable for performance or, alternatively, provide information that leads to improved safety.
The Patient Safety and Quality Improvement Act of 2005 promotes the goal of improving patient safety and reducing medical errors by establishing a system in which health care providers can voluntarily collect and report information related to patient safety, health care quality, and health care outcomes.
Providers are subject to legitimate external obligations regarding certain records about patient safety to ensure accountability and transparency. The Centers for Medicare & Medicaid Services and the Hospital Condition of Participation for Quality Assessment and Performance Improvement require hospitals to track adverse patient events. State health care regulatory agencies typically have separate requirements for different types of providers. The legal system provides another course to pursue accountability for medical errors. If a patient is injured while under a provider’s care, the tort system offers an avenue to compensate the patient for injury.
The intent of the system established by the Patient Safety Act is to protect the additional information created through voluntary patient safety activities, not to protect records created through providers’ mandatory information collection activities. The Patient Safety Act recognizes the goal of accountability and transparency and attempts to improve patient safety by reducing medical errors. Congress was aware of the chilling effect the fear of being sued had on providers, however, the Patient Safety Act was not designed to prevent patients who believed they were harmed from obtaining the records about their care.