The Scope of the Patient Safety and Quality Improvement Act: Does It Extend Beyond Patients?

August 7, 2023 by

In 2005, the United States Congress enacted the Patient Safety and Quality Improvement Act (PSQIA) to create a voluntary program that encourages healthcare providers to share information on patient safety events with patient safety organizations (PSOs). The Federal Act’s primary objective is to foster a culture of safety and enhance healthcare quality nationwide. While the title implies a focus on patients, a recent interpretation of the Act by Florida’s First District Court of Appeal has expanded the PSQIA’s scope of protection to reports involving not only patients but visitors and staff as well.


Understanding the Patient Safety and Quality Improvement Act (PSQIA)

The PSQIA was enacted to address the need for improving patient safety within the healthcare system. Its central aim is to encourage healthcare providers to share information about patient safety events with PSOs. These PSOs serve as designated entities that collect, aggregate, and analyze patient safety data, facilitating learning and improvements in patient care practices. By promoting a culture of transparency and open communication, the PSQIA aims to identify and prevent medical errors and adverse events, ultimately enhancing patient safety and healthcare quality across the nation.


Privilege and Confidentiality Protections under the PSQIA

 One of the most crucial aspects of the PSQIA is the privilege and confidentiality protections it affords to certain patient safety reports. These protections shield the information shared with PSOs from discovery in legal proceedings, ensuring that healthcare providers can report incidents candidly without fear of liability or retribution. The confidentiality provisions are designed to foster an environment where healthcare providers can openly discuss and learn from safety events, leading to systemic improvements in patient care.


Expanding the PSQIA’s Scope: Visitors and Staff Included

The interpretation of the PSQIA’s scope was recently scrutinized in the case of Shands Teaching Hospital and Clinics, Inc. v. Beylotte, 357 So.3d 307 (Fla. 1st DCA 2023). In Shands v. Beylotte, a dispute arose between Shands and Kimberly Beylotte following a slip-and-fall incident. Beylotte, who was visiting a patient at Shands, slipped and fell on a clear liquid in a hallway near a nursing station, resulting in injuries. Beylotte sued Shands for her injuries and sought disclosure of an “investigative report” related to her fall. Shands objected to the request and submitted an uncontradicted affidavit certifying that the report was prepared “solely for submission to a patient safety organization” and was “placed in a patient safety evaluation system and submitted to the patient safety organization” and therefore not subject to disclosure.


The trial court, however, granted Beylotte’s motion to compel the report’s production, asserting that the PSQIA only applied to records involving patients and not to incidents involving staff or visitors. As a result, Shands filed a petition for a Writ of Certiorari seeking to challenge the trial court’s decision. Shands’ petition was granted, and the appellate court reversed the trial court’s order holding that an investigative report related to a visitor’s slip and fall injury was deemed privileged and confidential under the PSQIA.


At issue for the court was whether the investigative report constituted “patient safety work product under the Act.” In its analysis, the appellate court noted that the Act protects “any data, reports, records, memoranda, and analyses (such as root cause analyses), or written or oral statements”:


(i) which –


(I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or


(II) are developed by a patient safety organization for the conduct of patient safety activities;


and which could result in improved patient safety, health care quality, or health care outcomes; or


(ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.

42 U.S.C. § 299b-21(7)(A).


The appellate court reasoned that because the report was assembled by a healthcare provider specifically for reporting to a patient safety organization, was actually submitted to a patient safety organization, and has the potential to contribute to improved patient safety, it met the criteria to be classified as patient safety work product and was therefore privileged and confidential under the Federal Patient Safety Quality and Improvement Act. Shands v. Beylotte, 357 So.3d 307 at 309 (also citing generallyTallahassee Mem’l Healthcare, Inc. v. Wiles, 351 So.3d 141 (Fla. 1st DCA 2022). The appellate court’s decision to uphold the privilege in this context highlights the Act’s extension beyond patients.


Implications of the Extended Coverage


The interpretation of the PSQIA’s scope to include visitors and staff under its protection has significant implications. It reinforces the importance of broad confidential protection to incident reporting to PSOs in healthcare settings to improve overall safety. By encouraging the investigation of incidents involving visitors and staff, healthcare facilities can also identify potential hazards that may equally impact patients. This approach fosters a holistic view of safety within healthcare settings.


Moreover, extending the privilege and confidentiality protections to incident reports involving visitors and staff leads to greater transparency and accountability. When healthcare facilities are assured that their reports are protected, they are more likely to investigate and report incidents openly. This enables them to proactively address potential safety issues and maintain an environment that prioritizes safety and continuous improvement.



About the Author

Maria D. OrtizAttorney

Maria Ortiz is an experienced bilingual litigator with a diverse background.  She has litigated cases in federal and state courts; a fighter by nature who takes pride in representing health care professionals, hospital systems and physician practice groups.

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