A white paper discussing Trends in PSQIA litigation can be found here.

If you should have any questions regarding any PSQIA opinion, please do not hesitate to contact AQIPS.

DNC v. Brajer, Eastern District of North Carolina

On December 20, 2016, a settlement agreement was executed and the DRNC dismissed the Complaint ( in DRNC v. Brajer.  AQIPS served as an expert witness on whether the PSES was designed properly and how following the process created PSWP.
Disability Rights North Carolina (DRNC) investigated a fall in a Behavioral Health facility.  All documents required to be maintained and turned over to DRNC that were provided to DRNC before the passage of the PSQIA (e.g., the factual incident report) were provided to DRNC.  DRNC learned that additional investigations and peer review documents were developed and held in the PSES and filed suit.  DRNC alleged that they were authorized to the documents under the "reporting pathway" of the PSES - as the documents were developed for more than one purpose.   The argument included the fact that the titles of the documents included titles of documents that the regulations provided that DRNC was entitled to (e.g., management investigations).   The defendant, represented by NC DOJ provided evidence that the PSQIA  preempted the Disability Rights statute and rules and the information they wanted was PSWP developed under the analysis pathway and the list of documents was also PSWP as it identified the analysis of the PSES under the analysis pathway.  The A&D pathway is not subject to the reporting pathway's "purpose" test.  DRNC settled the case.
See Peggy Binzer, J.D.'s expert statement here.
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  Sampling of PSQIA Case Law

Case Title

Case Number / Court

Case Summary

Tibbs v. Goff, et al.,

2012 –SC-000603

Decedent passed away after surgical complications.  University of Kentucky Hospital generated an incident report via the Hospital’s PSES, the Patient Safety Net computer system, and which was submitted to a PSO.  During an ensuing medical malpractice lawsuit, the defendants sought a protective order concerning the incident report under the PSQIA.  The trial court denied the motion, holding that the material was not PSWP relying on inapplicable precedent out of the New York state court system. Petitioners sought a writ of prohibition from the Kentucky Court of Appeals. A divided panel held that he PSQIA privilege extended only to documents containing a “self-examining analysis” and remanded the matter to the trial court to conduct an in camera review to determine whether any contained “self-examining analysis.”

The Kentucky Supreme Court reversed the Court of Appeals decision. The Kentucky Supreme Court held that the incident reports at issue were not privileged patient safety work product.

The incident report in question could not be PSWP because “its collection, creation, maintenance and utilization is mandated by the Commonwealth of Kentucky as part of its regulatory oversight of its healthcare facilities.”902 KAR 20:016§3(3)(2)” “Under Kentucky law, these types of reports are required in the regular course of business, are hospital records, and, are generally discoverable.” Remanded with an order to conduct an in camera review for a determination of privilege issues.  Abramson, J., Dissenting):  The likely result of such a decision is the wholesale dismantling of the safety culture system Congress intended to create.  “It is hard to imagine a holding more at odds with Congress’s clear intent to foster provide trust in the patient safety system”… then permitting a trial court to “rummage through the provider’s patient safety evaluation system and PSO submissions: in search of state-mandated records; and which “would completely undermine Congress’s assurance to providers that they may participle in the patient safety system without fear of liability or harm to reputation.” A collapse of voluntary reporting would inevitably diminish the ability of health care systems to improve patient safety by identifying and correcting faulty systems, processes, and conditions. This, in turn would “undercut the [Patient Safety] Act’s effectiveness in advancing patient safety” and may lead to increased patient injuries and deaths.

Petitioners petitioned the US Supreme Court for A Writ of Certiorari To The Kentucky Supreme Court. (Tibbs v. Bunnell, No. 14-1140).  SCOUS denied Certiorari.

Baptist Health Richmond v. Agee and Clause


Baptist Health Richmond v. Agee and Clause, a medical malpractice case in which the trial court was asked to compel the production of “any and all incident reports, investigation reports, sentinel event reports, root cause analysis reports, Joint Commission reports, Medicare reports, Medicaid reports, peer review reports and reports of any nature relating to [the decedent]”. The hospital identified responsive documents but argued that they were privileged and confidential PSWP. The trial court ruled that only those documents that had been “collected, maintained, or developed for the sole purpose of disclosure to a Patient Safety Organization pursuant to the [Act]” are protected.


The hospital appealed to the Court of Appeals seeking a writ of prohibition, which was denied on the grounds that the trial court’s “sole purpose” decision was consistent with the Kentucky Supreme Court’s decision in Tibbs. The hospital then appealed this denial. The Kentucky Supreme Court vacated the trial court’s discovery order and remanded the case back to the court with directions to follow its opinion in determining whether the documents requested are or are not privileged and confidential PSWP. The court directed that the existence of the Act does not relieve providers from fulfilling their statutory and regulatory reporting obligations. As long as a provider fulfills those obligations, the trial court has no reason to review the information in the provider's patient safety evaluation system. However, if a provider fails to fulfill those obligations, the court can conduct an in camera review of the documents in the provider's patient safety evaluation system. In conducting that review, the court should separate the information that is usually contained in state- mandated reports from information that is not usually contained in those reports. The information that is usually contained in state-mandated reports is not protected by the patient safety work product privilege provided in the Act and will be discoverable. Because the provider is claiming the privilege, it
bears the burden of proving that it complied with the statutory and regulatory reporting requirements. If the provider fails to meet that burden, the party seeking the information then bears the burden of establishing what information is generally contained in state-mandated reports.

Southern Baptist Hospital of Florida, Inc. v. Charles

178 So. 3d 102 (Fla. Dist. Ct. App. 2015)


Medical malpractice plaintiffs filed discovery requests seeking documents related to (1) adverse medical incidents, and (2) related to any physician who worked for the hospital or related to treatment rendered by the Hospital for three years preceding the incident resulting in adverse incident reports.

Hospital produced numerous documents, including state-mandated Code 15 reports, annual reports and two “occurrence reports” relating to the patient, which were removed from the PSES before being reported to the PSO. The Hospital refused to release PSWP reports. Plaintiffs moved to compel production of the occurrence reports arguing that the Patient Safety Act protects only those documents, which are created solely to transfer to a PSO.  The court ordered the documents produced, holding that the documents were created, in part, to satisfy state regulatory requirements and, therefore, were not protected.

The defendant appealed and a Florida district court of appeals endorsed petitioners’ view stating that records maintained in a patient safety evaluation system are privileged even if they are prepared to comply with a “state statute, rule, licensing provision, or accreditation requirement.”  The case is presently on appeal to the Supreme Court of Florida.





Gooden, et al., v. CVS Caremark Corp





Case No. 11CVA-10885 (2012) (Ohio Court of Common Pleas)

The pharmacist created an incident report on January 31, 2011, which was the day, or the day after, the pharmacy learned of the error.  The defendant’s PSO had immediate access to the report through functional reporting. The error was corrected.  The patient profile was also corrected to prevent any future occurrence of the error.

Plaintiff filed suit and moved to compel the incident report to which Defendant objected because it constituted patient safety work product.

The Court disagreed based on the “evidence provided.”  The Court upheld the PSWP theory. 










Awwad v. Largo Medical Center










2012 WL 1231982 (M.D. Fla. Apr. 12, 2012):

Dr. Awwad sued Largo Medical Center (“LMC”) claiming that an adverse employment action was the result of improper discrimination.  During discovery, Dr. Awwad asked LMC to produce credentialing and peer review files, and other related information.  LMC opposed producing this information on multiple grounds, including the PSQIA.  The Court ruled that, from the evidence presented to it, the PSQIA “… appears inapplicable to the circumstances of this case.”  Although the record in devoid of factual detail, it appears from the language used by the Court that LMC did not provide sufficient evidence to establish that a PSO existed or that the information sought was created for the purpose of reporting an incident to a PSO.






Department of Financial and Professional Regulation v. Walgreen Co.






9 70 N.E.2d 552 (Ill. App. Ct. 2012):

On July 1, 2010, Walgreens was served with subpoenas requesting “all incident reports of medication errors” involving three of its pharmacists who apparently were under investigation by the Illinois Department of Professional Regulation (“IDFPR”) and the Pharmacy Board. Walgreens objected – IDFPR sued.

Walgreens submitted affidavits to contend that the responsive documents were collected as part of its Strategic Reporting and Analytical Reporting System (“STARS”) that are reported to their component PSO and further, that it did not create, maintain, or otherwise have in its possession any other incident reports other than the STARS reports.

Trial court rules in favor of Walgreens Motion to Dismiss finding that: “Walgreens STARS reports are incident reports of medication errors sought by the Department in its subpoenas and are patient safety work product and are confidential, privileged and protected from discovery under the PSQIA.

IDFPR Appealed. The Appellate Court unanimously affirmed the circuit court’s decision to dismiss the IDFPR’s lawsuit, which sought to require production of incident reports that the circuit court found to be PSWP – privileged and protected from discovery – under the PSQIA.







Morgan v. Community Med’l Center Healthcare Sys.







Case No. 08-CV 4859 (2011) (PA Ct. Comm. Pl., Lackawanna County)

Plaintiffs sued Community Medical Center Healthcare System (“CMCHS”) for a fall that occurred immediately after Mr. Morgan was discharged from CMCHS’ emergency room.  Plaintiffs contend that Mr. Morgan should not have been discharged from the emergency room, and that the improper discharge led to his fall/injuries.  During discovery, the Plaintiffs sought an incident report prepared by CMCHS.  The Court interpreted the PSQIA to apply solely to information prepared as a part of a patient safety evaluation system.  Based on the evidence presented, the Court found it could not state definitively that the incident report was used solely for that purpose.  As a result, the Court ordered its disclosure.   

Tinal v. Norton Healthcare, Inc.


(W.D. KY), No. 3:11‐CV‐596‐S, May 8, 2014


In Tinal, the plaintiff, a pharmacist employed in the Norton Hospital system for almost a decade, was discharged in September 2010.  She asserted that the defendant employer, Norton Healthcare, Inc., fired her in violation of the American with Disabilities Act after she returned from brain surgery.  Norton contended that the plaintiff was discharged for a series of dispensing errors.

During the course of discovery, plaintiff sought production of a number of documents over which the defendant claimed privilege under the PSQIA.  These included records of all errors committed by pharmacists at the hospital in which she was employed for a three year period, records containing Root Cause Analysis, and records concerning patient harm or adverse consequences allegedly caused by the plaintiff. Plaintiff sought the records of errors of other pharmacists in order to show that other pharmacists with similar error histories were not terminated.  Plaintiff moved to compel production of the documents, asserting that the privilege did not apply to employment discrimination cases.  Defendant objected, placing a number of issues relating to the privilege squarely before the court.

First, the court affirmed the broad scope of discovery under the federal rules of civil procedure, particularly in the context of employment discrimination actions.  Second, the court concluded that Congress’s primary concern in enacting the PSQIA was “to limit the medical malpractice exposure of healthcare providers” which align themselves with PSOs.

The court held that, under the plain and ordinary meaning of the statutory text, the privilege applied outside the context of medical malpractice actions to encompass litigation such as employment discrimination actions.  In doing so, the court relied upon the statutory provisions indicating that patient safety work product shall not “be subject to discovery in connection with a federal, state, or local, criminal or administrative proceeding” nor “admitted as evidence in any federal, state or local governmental proceedings.”  The court noted that no exception was created for federal civil rights or employment discrimination actions.  The court held that in light of the unambiguous language of the statute, it was powerless to fashion an exception for employment actions despite the “substantial obstacles” the privilege placed before the plaintiff seeking to prove discrimination.

The court next examined plaintiff’s challenge that the documents did not meet the statutory criteria necessary to be privileged.  The court examined affidavits of Norton employees and conducted an in camera review of the eighty-four documents over which the privilege was claimed. The court found that the “documents included within the privilege log for the Court’s review were reported by Norton to a listed PSO on various dates as part of its [patient safety evaluation system].”  The log contained sufficient information to enable the court to conclude that each document satisfied the statute’s criteria to be patient safety work product.  The court held that the privilege log satisfied the specificity requirements of the federal rules of civil procedure demanded of such documents.


Johnson v. Cook County


2015 WL 5144365

N.D. Ill., Eastern Div.

Plaintiff alleges that various systemic failures in intake medical screening at the Jail and a deliberate indifference to Mr. Johnson’s medical needs caused his death.  The entity responsible for providing medical care to inmates at the Jail, conducted a morbidity and mortality review of Mr. Johnson’s death. The findings and recommendations of the morbidity and mortality review are memorialized in the Report prepared after Mr. Johnson’s death. Plaintiff sought to compel production of that Report.

The Court found that Defendant has not met its burden of establishing the Report is PSWP.  At the outset, Defendant has not met its burden of establishing the Report was reported to a PSO as required by the statute. Defendant provided no evidence that the report was functionally reported to the PSO (no affidavit). Defendant did not know which PSO they belonged to.  No evidence that the PSO provided feedback. No PSES documented.  Defendant followed Jail policy.