How Integrated QAPI and Risk Management Practices Can Reduce Harm and Manage Legal Discovery Risks

ECRI Institute and Annals of Long-Term Care: Clinical Care and Aging (ALTC) have joined in collaboration to bring ALTC readers periodic articles on topics in risk management, quality assurance and performance improvement (QAPI), and safety for persons served throughout the aging services continuum. ECRI Institute is an independent nonprofit that researches the best approaches to improving health care.
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A shift from quality assessment and assurance (QAA) to quality assurance and performance improvement (QAPI) is becoming a regulatory reality for providers across the aging services continuum, affecting both home health and nursing providers. Besides the Centers for Medicare and Medicaid Services, there is an increasing number of state regulatory licensing programs for assisted living programs adopting similar continuous quality improvement models. 

QAPI involves the use of tools and methods to identify, examine, assess, and candidly evaluate adverse events and quality of care, with the goal of taking action to reduce and prevent harm through continuous improvement of organizational systems and processes. These activities are grounded in the premise that internal investigation and critical evaluation are essential processes for mitigating harm and improving quality of care.

However, in the event of litigation against an aging services provider organization, potential legal discovery of QAPI processes and work product may pose a problem to the organization. Litigation involves a procedural tool referred to as “discovery” through which parties to a lawsuit may seek to “discover” information and material that are not privileged and that are relevant to the subject matter of the litigation. Discovery is grounded in the premise that litigation is a truth-seeking process that culminates in dispute resolution.

The new regulatory reality calls for a renewed discussion about how aging services providers may appropriately invoke privilege from discovery to protect quality improvement (QI) “work product” from disclosure in litigation. Why? Because the Federal Nursing Home Reform Act and its implementing regulations for QAPI programs for nursing facilities provide protection from disclosure as follows: “A state or the Secretary may not require disclosure of the records of [a QAPI] committee except insofar as such disclosure is related to the compliance of such committee with the requirements of this section”^1,2

The processes and goals of QAPI and litigation discovery can create a juxtaposition of two very real but seemingly opposing provider risks. The organization can be harmed if “problems” are discovered and QAPI information is used against the provider in litigation. At the same time, the organization can certainly be harmed by failure to act to prevent reoccurring incidents with common root causes. That is, in trying to do the right thing and prevent someone else from being harmed in a similar way, a provider might be forced to produce its QI work in certain circumstances causing harm to the organization. One unintended consequence of these seemingly competing risks is that a fear of harm to the organization discourages correction of identified problems that represent a potential harm for those served. Provider organizations should also remember that a failure to operationalize QAPI practices also presents risks associated with regulatory noncompliance. Ultimately, effective management and mitigation of these risks are important for the persons served by provider organizations and for the organizations themselves.

Accordingly, QAPI should be designed and structured to function in ways that optimize the chances that QAPI work product will satisfy privilege requirements, thereby helping to avoid feelings of a “darned if you do, darned if you don’t” situation. Using a systems thinking approach is one way to help meet privilege requirements and help manage both risks.

Systems Thinking Overview

A systems thinking approach pushes providers to understand environments of all types through a greater appreciation of how all parts of a system—structures, processes, and people—interrelate. Applied to care and service environments, systems thinking embraces the concept that the whole is greater than the sum of its parts. When individual parts of a care and service environment are highly integrated, are aligned with the organization’s mission and external environments, and act to support one another as part of daily and ongoing operations, it will be easier to establish and sustain an environment that inhibits adverse events and harmful or potentially harmful outcomes (Figure 1). 

A systems thinking approach also encourages facilities to address organizational problems and solutions in relation to the realities in which they exist.

Reality 1. 

There is no guarantee that any document is protected by a privilege; courts determine whether privilege applies on a case-by-case basis. Courts typically attempt to construe discovery broadly enough to serve the purpose of truth-finding in litigation yet narrowly and strictly enough to avoid unjustified “secreting” of relevant information.

Reality 2. 

A party claiming a privilege must demonstrate to the court that the privilege applies. Demonstrating by design, implementation, and adherence to practices that meet the intent and letter of the asserted privilege helps build a strong legal argument that privilege applies. Federal and state case law provides real examples of lessons learned by litigants. Court opinions in privilege cases typically explain the facts, circumstances, and legal reasoning for granting or denial of a privilege. Case law may also provide guidance that facilities can use to create QAPI processes that optimize conditions for the application of a privilege.³

Keeping these realities in mind, aging services organizations should remember that “bundling” of practices strengthens their effectiveness for all stakeholders—persons served, employees, and the organization itself. Bundling can be achieved by designing and integrating risk management and QAPI practices so as to reduce risks, improve quality, and increase safety. By continually developing a culture that values a common purposefulness and unity, a provider can create a new paradigm for addressing seemingly competing risks. In this new reality, implementing QI activity and processes designed to earn privilege protections effectively integrates otherwise competing interests. A paradigm is created whereby realistic efforts to earn protection from discovery coexist with ongoing improvement activities to prevent future similar events from occurring. That is, the paradigm shift no longer requires selecting one over the other, but instead includes one and the other, for a stronger bundled approach.

Developing an Integrated Culture

Begin by increasing awareness among staff about risk management and QAPI functions and the purposes they serve within the organization by differentiating between initial investigations and performance improvement. Defining and mapping the differences between these two important functions will give staff a better understanding of where programs start and stop and why following process guidelines closely helps to integrate the functions and manage the risk that potential disclosure will inhibit efforts to improve quality and safety.

Risk management and QAPI functions are both vital to provider organizations. Exercising good organizational design and diligence can enable these processes to complement rather than compete with one another. Four important considerations can help in achieving an integrated systems thinking approach that encompasses both risk management and QAPI.

Consideration 1. 

Begin by establishing a clear definition of reportable incidents within the organization. Distinguish between initial investigation techniques, such as preparing incident reports and taking witness statements, and performance improvement analysis techniques, such as conducting interviews and performing root-cause analyses. The distinction between these techniques should be documented in written guidelines and policies and made operational.

To help distinguish between risk management and QAPI functions, consider the different nature of the assignments and documents used for the different purposes and goals of the two, ie, fact finding or ongoing performance improvement (Table 1). It is wise to begin by assuming that fact-finding documents such as incident reports, witness statements, and timelines may not meet the definition or intent of QI work product and therefore do not typically enjoy protection from discovery.

Consideration 2. 

Remember that just because a QAPI or QAA committee uses a particular document for QAPI activities does not mean that a court will conclude that the document automatically is a quality assurance document protected from discovery.

Consideration 3. 

Recognize that a clear distinction between initial investigations and QAPI activities allows for effective use of QAPI committees and clarifies their purpose. When a chartered QAPI committee directs and executes certain efforts in a manner consistent with QAPI intent, it creates a more favorable foundation for building an argument for privilege protection.

Consideration 4. 

Recognize that QAPI work product should demonstrate a primary purpose of improvement and thus should reflect efforts to prevent future episodes of harm. QAPI work product therefore should include performance improvement recommendations.

In Summary

Designing integrated risk management and QAPI systems that complement each other can help support an argument to protect certain documents, discussions, and activities during discovery. Designing an integrated risk and quality platform with guidelines to direct activities, bundling practices that strengthen each other, and following those practices consistently creates an environment that helps defense counsel construct a legal argument for protection of certain items on an organization’s behalf. Just as important, when provider organizations work to strengthen organizational functions, such as resident and patient safety, risk management, and quality improvement, they do so for the greatest of reasons: to provide the best care possible for the persons served.

To read more practical aging services risk management suggestions to help your organization manage risks related to possible discovery of quality improvement materials vs potential harm from repeated incidents and adverse events, download Legal Discovery and QAPI: A Tale of Two Risks at www.ecri.org/systems-thinking.⁴ This white paper includes additional guidance and legal case reviews that help to clarify this and related issues. 

To contact ECRI Institute directly for more information about their tools and services, please email ECRI’s Continuing Care Risk Management at ccrm@ecri.org.

References

1. Legal Information Institute, Cornell Law School. 42 U.S. Code § 1396r - Requirements for nursing facilities. Cornell Law School website. https://www.law.cornell.edu/uscode/text/42/1396r. Accessed September 26, 2017.

2. Legal Information Institute, Cornell Law School. 42 CFR 483.75 - Quality assurance and performance improvement. Cornell Law School website. https://www.law.cornell.edu/cfr/text/42/483.75. Updated October 4, 2016. Accessed September 26, 2017.

3. Neiman B. Nursing home’s incident investigation subject to discovery absent QA committee oversight. Much Shelist website. https://www.muchshelist.com/knowledge-center/article/nursing-homes-incident-investigation-subject-discovery-absent-qa-committee. Published March 29, 2017. Accessed September 26, 2017.

4. ECRI Institute. Legal discovery and QAPI: a tale of two risks. Continuing Care Risk Management. https://www.ecri.org/systems-thinking. Published September 2017. Accessed September 26, 2017.