Summary

The Need For Highly Reliable Health Care

The Institute of Medicine report Health IT and Patient Safety: Building Safer Systems for Better Care highlighted the unintended consequences of health IT-induced harm that can result in serious injury and death due to dosing errors, failing to detect serious illnesses, and delaying treatment due to poor human-computer interactions, confusing clinical terminology, or unreliable data quality (Institute of Medicine, 2012).

These forms of failure are often hard to anticipate and may go unnoticed or be misidentified downstream of the error source leading to repeated system failures and preventable patient harm. Up to 10% of patients are unnecessarily harmed while receiving hospital care in the United States. At least 50% of the patient harm due to healthcare-associated adverse events is preventable (Leatherman & Berwick, 2020).

Due to the inherent complexity of health information systems, multi-disciplinary professionals engaged in the delivery, support, and engineering of safer health outcomes must address these error conditions and factors in ways that reduce the likelihood of unsafe events rather than superficially focusing only on single root causes (Institute of Medicine, 2012).

High Reliability Organizations (HROs) such as aviation, nuclear power, and military operations rarely fail even though they encounter numerous unexpected events (Sullivan, et al., 2016).  HROs in health care settings employ operating principles which reduce the frequency and severity of system failures leading to preventable patient harm including:

• Sensitivity to Operations which is the heightened awareness of the state of relevant systems and processes

• Preoccupation with Failure supports the management of unexpected or unknown failures by recognizing near miss events  as opportunities to improve, rather than proof of success

• Commitment to Resilience allows HROs to anticipate, prioritize, and continuously improve processes, standards, and protocols for many unlikely, but possible, system failures.

Additional HRO principles include Reluctance to Simplifyand Deference to Expertise. These principles are underpinned by threeessential pillars of High Reliability: leadership comittment, culture of safety, and a continuous process improvement to meet emergent challenges ever present in a complex adaptive system such as health care delivery.

Implementing Highly Reliable Knowledge Solutions

the Solor Project, which focuses on efforts such as consistent representations of clinical statements through Analysis Normal Form (ANF), harmonization of medical terminologies using a Terminology Knowledge Architecture (Tinkar), and management and extension of disparate terminology data through Komet.

• Analysis Normal Form (ANF) is a HL7 informative logical model intended to represent a normalized view of aggregate clinical statements recorded during treatment for analysis, research, clinical decision support, and other purposes. At a high-level an ANF statement defines the topic (WHAT happened, was observed, requested, measured, asserted, etc.) and under what circumstances (HOW, WHY, WHEN, and with what RESULT).

• The Terminology Knowledge Architecture (Tinkar) project, currently within HL7’s Vocabulary Working Group, begins the work to define a flexible, self-describing standard logical model for format and distribution of terminology knowledge bases. Current creation of the Tinkar logical model and HL7 ballot artifacts are in progress and on target for May 2021 informative ballot cycle.

• The Knowledge Management Environment (Komet)provides an open-source ecosystem for management, harmonization, and extension of medical terminologies. Komet allows users to import, transform, view, extend, and export content from disparate medical terminologies, all in one common model. Users can navigate and search Solor content, view details of the data elements, and select specific concepts to view more information.

High Reliability Organization (HRO) Recommendations for Knowledge Management

The following four high-level potential deficiencies related to preventable harm that an HRO approach to knowledge management should address:

1. Recognizing equivalence between different standards that are representing the same clinical data (HRO Sensitivity to Operations)

2. Representing clinically significant concepts that are needed in a systems of record, such as an EHR, unambiguously (HRO Preoccupation with Failure)

3. Preventing the inclusion and/or perpetuation of errors in clinical data represented within a systems of record (HRO Commitment to Resilience)

4. Ensuring the safe and reliable evolution of terminology standards, solutions, and processes as new technologies and policies are implemented (HRO Commitment to Resilience)

Impact on Strategies

• Ties to the requirement or need from the implementation committee for a unique fingerprint

References

1. Enabling Highly Reliable Data Governance at the U.S. Department of Veterans Affairs (VA) Keith E. Campbell, MD, PhD Director of Informatics Architecture VHA OHI CIDMO KBS