Notwithstanding their entrance into the healthcare world and lexicon 15 years ago, Patient Safety Organizations (“PSOs”) continue to represent a source of uncertainty, confusion and frustration with respect to their promise of sweeping confidentiality protection for provider efforts to analyze system errors. Not surprisingly, a recent report from the Office of the Inspector General of the U.S. Department of Health and Human Services noted that 89% of PSOs offer at least one learning-based service such as webinars, in-person training or technical assistance.
This article provides: (a) an overview of the Patient Safety and Quality Improvement Act (“PSQIA”); (b) the competing legal interests at work when providers seek to invoke confidentiality protection included in the PSQIA; (c) relevant questions for providers to ask as they assess if they have an adequate patient safety system to protect their confidentiality interests, or whether training and further refinement of systems would prove helpful; and (d) practice tips to help providers avoid inadequate procedures and the pitfalls they cause.
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Background
In 2005, Congress enacted the PSQIA with the goal to improve patient safety by encouraging learning from medical errors and safety events. The PSQIA created PSOs, which are private organizations that serve as patient safety experts. To encourage providers to utilize PSOs, the PSQIA establishes confidentiality and privilege protections for data submitted by a health care provider to a PSO.
PSOs are intended to encourage voluntary, provider-driven initiatives to improve health care quality and safety by aggregating, analyzing, and reporting on patient safety data. The PSQIA also created the Network of Patient Safety Databases (“NPSD”) which receives de-identified data from PSOs and can utilize that data to review national statistics, trends and patterns underlying causes of risks and harms in the health care delivery system.
Confidentiality and Privilege Protections
The PSQIA provides privilege and confidentiality protections to data reported to a PSO. In order to obtain these protections, a provider must set up a Patient Safety Evaluation System (“PSES”) that manages data collection, management, analysis, and ultimate reporting to the PSO. The PSES can function under the auspices of a provider’s Patient Safety Committee so long as the PSES defines which events and processes will be reported. Data that flows through the PSES is considered Patient Safety Work Product (“PSWP”) and is subject to confidentiality and privilege protections, meaning the data cannot be discovered in litigation and used against the provider. Examples of information that should flow through the PSES are impressions not available in the medical report, data that is not required to be reported under other mechanisms, and other information that could be damaging in litigation.
The PSQIA provides three pathways through which data is considered PSWP:
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- Reporting Pathway: Data, reports, records, memoranda, analyses, and written or oral statements which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO. 42 U.S.C. §299-21(7)(A)(i)(l).
- Analysis and Deliberations Pathway: Data, reports, records, memoranda, analyses, and written or oral statements which identify or constitute the deliberations or analysis of, or identify the fact or reporting pursuant to, a PSES. 42 U.S.C. §299-21(7)(A)(ii).
- Patient Safety Organization Pathway: Data, reports, records, memoranda, analyses, and written or oral statements which are developed by a PSO for the conduct of patient safety activities and which could result in improved patient safety, health care quality or health care outcomes. 42 U.S.C. §299-21(7)(A)(i)(ll).
Underlying facts, medical record documentation, billing and discharge information are not considered PSWP. Similarly, information collected, maintained, developed separately or existing separately from a PSES is not PSWP.
Issue
Hospitals and other providers with a PSES in place typically discover whether their systems pass muster when confronted with medical malpractice cases and requests from plaintiffs’ lawyers for incident reports and similar analyses relating to the injury at issue in the lawsuit. The question before the court becomes: have the hospitals not only created clear, precise and understandable policies and procedures that are suitable to protect PSWP, but have those same hospitals adequately implemented the system so as to protect and preserve its confidentiality?
Tension
Hospitals and other similar providers creating and implementing PSES must closely follow statutory and regulatory requirements to maintain confidentiality because they will face courts skeptical of evidentiary privileges that appear to many judges to operate to blunt or undermine a Plaintiff’s day in court. The Pennsylvania Supreme Court in the 2017 case of Reginelli v. Boggs, 181 A.3d 293 (2018) expressed this skepticism succinctly: “evidentiary privileges are not favored as they operate in derogation of the search for truth.” While the Reginelli case involved the scope of confidentiality under the Pennsylvania Peer Review Protection Act (“PRPA”), not the PSQIA, it serves to highlight judicial disfavor toward evidentiary privileges. That premise is balanced against statutory privileges, such as those residing in the PSQIA for patient safety information. While a court will enforce a privilege, as the Supreme Court made clear in Reginelli, it will strictly construe any evidentiary privilege and decline to enforce it if the privilege has not been properly observed by the hospital. While that can happen in a myriad of ways, four basic traps include: (a) failing to create appropriate policies and procedures; (b) not transferring data through pathways as required for PSES or PSO compliance; (c) removing the patient safety information from the PSES; or (d) failing to provide the court with adequate evidence to establish that the hospital and other providers have properly followed the statutory requirements of the PSQIA.
Protection
As discussed above, courts will not enforce a privilege if they find that the owner of the privilege has not studiously followed all statutory and regulatory requirements to protect that information, whether that is reflected as a defect in the policies and procedures as drafted and promulgated, or as implemented by the hospitals.
Accordingly, hospitals should keep the following in mind as they consider or reconsider the adequacy of their patient safety policies and procedures as drafted and implemented.
- Has the hospital drafted its patient safety policies and procedures so as to mimic the requirements as found in the PSQIA?
- Are the policies and procedures clear, simple and understandable for those employees tasked with implementing the policies and procedures?
- Has the hospital consistently applied patient safety procedures so as to avoid arguments of waiver that will benefit plaintiffs in an evidentiary dispute and trigger the courts’ predilection to order the production of ostensibly confidential incident reports because evidentiary privileges “are not favored as they operate in derogation of the search for truth?”
- Has the hospital carefully, consistently, and with legal precision maintained the security of the relevant information, meaning that they have not inadvertently removed confidential information from the PSES system or shared the same with unauthorized personnel or unrelated third parties?
- Does the hospital have procedures in place for regular training and re-training employees who are tasked with the duties to create, maintain and transmit PSWP so that they fulfill all statutory and regulatory requirements to maintain confidentiality?
Affidavit
The test of a hospital’s patient safety system manifests itself in a courtroom discovery battle. In that setting, the hospital, to maintain its privilege, will typically need to submit to the court an effective affidavit that reflects it has policies and procedures in place that are in strict compliance with the rules and requirements of the PSQIA. In addition, the hospital will need to establish that it has implemented the rules and requirements in strict compliance with the Act. This will require, in the typical case, making the policies and procedures an exhibit to any relevant affidavit and a sworn statement by a patient safety officer that the hospital has, indeed, strictly followed the plain language of the policies and procedures that match up with the rules and requirements of the PSQIA.
Practice Tips
To prevail in an evidentiary privilege battle, astute hospital-litigants will generally outline and/or draft a template affidavit for use in court prior to the commencement of a lawsuit that reflects what must be established to optimize the potential for enforcement by the court of relevant PSQIA confidentiality privileges. A hospital should then work backward from, and with reference to, the template affidavit to ensure that it has all relevant policies and procedures in place and implemented a system in strict compliance with PSQIA requirements. In short, the template affidavit serves as an internal checklist of PSQIA requirements as well as a litigation vehicle to protect PSQIA confidentiality privileges. Having such an affidavit on hand and a tightly-drawn and functioning PSES is the best way to prepare for and win discovery battles and maintain confidentiality protection for PSWP. Part and parcel of this effort is a regular review of relevant policies and procedures, vigilant oversight of PSES implementation, and regular training and/or retraining to ensure staff understands and correctly and consistently apply the provider’s system.
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Charles Kelly, a partner at Saul Ewing Arnstein & Lehr, is a highly regarded litigator with extensive experience handling media, healthcare and complex commercial litigation. He regularly litigates cases in federal, state and bankruptcy courts.
Charlie's clients range from Fortune 100 to small start-up companies that he represents for complex litigation issues, including breach of contract, tort, quasi-contract, fraud, negligent misrepresentation, copyright, trademark, trade name, libel, shareholder disputes, labor advice (including discrimination, constructive discharge, sexual harassment and disability matters) and non-compete and trade regulation/anti-trust claims. His clients operate in numerous industries, including food and pharmaceutical distribution, media, healthcare, specialty scrap, automotive and energy, among others.
Charlie advises clients in the hospital and ambulance industries on healthcare issues such as Medicare and Medicaid regulations, False Claims Act cases and sophisticated coding and reimbursement issues.
Samantha Gross is an associate at Saul Ewing Arnstein & Lehr. She represents and counsels health care providers in regulatory and transactional matters. Samantha's experience includes drafting and negotiating contracts related to physician arrangements, health care mergers and acquisitions, and group purchasing organizations (GPOs). Her regulatory experience includes counseling on hospital operations, medical staff issues, changes in ownership, regulatory licensing, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as federal and state fraud and abuse laws.
Samantha brings a diverse perspective to her representations of hospitals, physician groups, long-term care organizations, GPOs, and pharmacies. In addition to her work in private practice at a national law firm, Samantha has previously worked as in-house counsel for a Philadelphia health system. In addition to her law degree, she has a Master's of Public Health from the University of Pennsylvania.
