Author Spotlight:

Tracy Chamblee


Patient Safety & Quality Executive

In the U.S., healthcare is a highly regulated industry. From the Health Insurance Portability and Accountability Act (HIPAA) to the Patient Protection and Affordable Care Act (ACA), numerous laws, rules, regulations, etc., that are designed to protect public wellbeing.

Another key law to understand is the Patient Safety and Quality Improvement Act of 2005 ( ), which facilitates the confidential gathering of information about patient safety events. The PSQIA is an important pillar of the healthcare system and benefits providers, payers, and patients by reducing medical errors and improving patient care.

In response to the 1999 landmark Institute of Medicine report, To Err is Human: Building a Safer Health System, the PSQIA (Public Law 109-41) was signed on July 29, 2005. The overarching goal of the PSQIA is to improve patient safety by encouraging voluntary and confidential reporting of adverse events and unsafe conditions that may contribute to patient harm.

The PSQIA reflects the Federal Government’s commitment to fostering a patient safety culture. It outlines a framework to establish Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers. PSOs can receive reports on quality and safety from any health care provider, including hospitals, doctor’s offices, nursing homes, or ambulatory surgery centers. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the U.S. Department of Health and Human Services (HHS), the PSQIA “encourages a culture of safety in healthcare organizations.”

Prior to the PSQIA, fear of legal discovery restricted discussion of patient safety events and contributed to a lack of reporting and data to review and analyze. The PSQIA allows PSO’s to analyze event data to identify trends and other opportunities to improve the quality of patient care across all healthcare settings and provide recommendations to mitigate identified risks.

Today, providers fear that patient safety event reports could be used against them in medical malpractice cases or disciplinary proceedings. However, the PSQIA specifically addresses these fears by providing Federal legal privilege and confidentiality protections to 1)  all information that is assembled and reported by providers to a PSO or developed by a PSO  for the conduct of patient safety activities referred to as patient safety work product (PSWP) and 2) how the patient safety information is collected developed, analyzed, and maintained, referred as the patient safety evaluation system (PSES).

 I hope that anyone who reads this blog will take the time to understand the main message of the PSQIA. The healthcare workforce should be familiar with PSOs and the protections they provide, feel empowered to report safety concerns, and confident that those reports will remain strictly confidential.