The Affordable Care Act requires that by January 1, 2017, hospitals with more than 50 beds that contract with Qualified Health Plans (QHPs) participate in a Patient Evaluation System (PSES) through a federally certified Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act (“PSQIA”) was enacted by Congress in 2005 to provide broad legal protections and confidentiality of patient safety information reported to a PSO, known as Patient Safety Work Product (“PSWP”). For hospitals, this law may enhance those state and local protections already in place; however, the PSQIA holds the prospect of new protections for non-hospital providers, such as medical groups, home health providers and long-term care providers.
Patient Safety Work Product
The PSQIA provides that, “patient safety work product shall be privileged and shall not be subject to discovery in connection with a Federal, State or local civil or administrative proceeding.” By statute, PSWP means:
“…any data, reports, records, memoranda and analyses (such as root cause analyses) or written or oral statements which: (1) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or (2) 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 healthcare outcomes; or (3) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.”
The legal boundaries of what constitutes protected PSWP are rapidly evolving. Certain categories of information are clearly not PSWP: (1) Patient medical records; (2) billing records; (3) discharge information; and (4) Information collected, maintained or developed separately from a PSES.
An often cited local case is Dep’t of Fin. & Prof’l Regulation v. Walgreen Co., decided by the Second District of the Illinois Appellate Court in 2012. This case revolved around an incident reporting system for medication errors developed and utilized by Walgreens and whether these incident reports had to be produced in response to an administrative subpoena issued by the Illinois Department of Financial and Professional Regulation. Walgreens claimed privilege over these reports, arguing that they were PSWP. The trial court ruled in favor of Walgreens and the IDFPA appealed. On appeal, the Walgreens Court found that the Walgreens reporting system, known as STARS, generated confidential quality improvement reports that were transmitted to a federally certified PSO. Walgreens also demonstrated that the STARS reports were not created for any purpose, other than transmittal to the PSO, nor did Walgreens create, maintain or possess any other medication error incident reports outside of the STARS reports. The Second District Court affirmed the trial court’s ruling that the reports were privileged pursuant to the PSQIA.
The Walgreens decision did not tackle the question of whether a federal privilege applies to patient safety information that is collected for purposes of compliance with state/local reporting requirements and for reporting to a PSO – the so-called “dual reporting” dilemma. This issue is currently pending before the U.S. Supreme Court, in the matter of Tibbs v. Bunnell, et. al .
Tibbs is a medical malpractice action against the University of Kentucky Hospital. The question at the heart of Tibbs is whether dual reporting negates the privilege against disclosure provided for in the PSQIA. In Tibbs, the hospital moved for a protective order concerning an incident report prepared by one of the nurses involved in the patient’s care, claiming that the report was created through the University of Kentucky’s PSES for reporting to the University Hospital Consortium PSO and therefore, was privileged as PSWP. The Kentucky Supreme Court found the report was not privileged because the information included in the report was of the type that would normally be included in an incident report required by Kentucky regulations. This decision was rendered despite the fact that the hospital was able to demonstrate that report was generated and stored in a database dedicated to the hospital’s PSES for reporting to a PSO. Other states have found that nowhere does the Patient Safety Act state that a document may not simultaneously be PSWP and meet state/local reporting requirements, and that the legislative history of the PSQIA supports a broader reading of the protection provided.
The greatest chances of success will be enjoyed by those PSO participants who are proactive and knowledgeable about this evolving area of law. Don’t hesitate to work collaboratively with in-house counsel, litigation counsel and consultants from your PSO to get out ahead of plaintiff’s attorneys who are becoming increasingly aware of the enhanced protections afforded by the PSQIA and are aggressively challenging them at all phases of litigation.
Points for Consideration
1. Only participation in a federally certified PSO qualifies for protection under the PSQIA;
2. You need to prove the existence of a true Patient Safety Evaluation System to be able to prove Patient Safety Work Product – documentation is key;
3. Define your PSES for your organization through proactive, multidisciplinary involvement to encourage preparedness for litigation challenges;
4. Logistical details of how data is collected, stored and ultimately reported to PSO can be important in a court’s determination of PSWP (e.g. who can report, where the data is entered, where data is stored, written policies or other documents regarding functionality of PSES).