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Learning from Root Cause Analysis (RCA) actions that use standardization to address patient safety concerns
Event Type
Oral Presentations
TimeWednesday, April 142:40pm - 3:00pm EDT
LocationPatient Safety Research and Initiatives
DescriptionBackground
There are clear benefits to standardization in certain environments: no one wants to guess at which side of the road to drive on, whether the electrical appliance you bought at the store will work on your home outlet, or how large the “one cup” specified in a recipe really is. Standardization can increase efficiency, reduce uncertainty, remove ambiguity, and enhance safety if done thoughtfully. Standardization as a tool or technique is often recommended for use in healthcare (Berwick, 1991). In addition, standardization is a tool commonly used in Lean, which has gained prominence as a process improvement method in healthcare settings.

However, there are limitations and hazards associated with standardization (Wears, 2015; Timmermans & Epstein, 2010; Fuller & Arnold, 2021). Standardization may influence system adaptability and resilience. For example, concerns about a particular product may not be identified prior to implementation, at which point the healthcare system may be without other options if administrators have standardized to one product. In addition, the outcome from product shortages will be more severe if a system has been standardized to remove alternatives. In general, standardizing without regard for unintended consequences may create dangerous situations in healthcare (Wears, 2015).

Wears (2015), citing Perrow (1967) and Reason (1997), noted two dimensions for determining when standardization might be helpful versus harmful: the number of “exceptional” cases and the difficulty in identifying a solution. To these dimensions, Wears added human variability such as the skills or knowledge of the actors, which may influence their perception of whether an event is novel and how easily a solution may be identified. Wears provided general examples of industries that are amenable to standardization (construction, assembly line operations) as well as those that are not (combat operations, crisis management). He noted that the middle ground, where much of healthcare lies, requires a combination of strategies. This generates the question: what things should be standardized in health care? Should equipment or facility layouts be designed to a certain standard? To what extent should these things be standardized? On what scale?

There are clear differences in the implications of standardizing physical spaces, equipment, software, interfaces, policies, and processes. There are considerations of permanency as well as the number and variety of participants. Variation in the users will influence issues of buy-in, compliance, agreement, capability, and needs. To gain a better understanding of these complex issues within the health care setting, we explored a patient safety database with actions proposed in response to adverse events.

Methods
The Veterans Health Administration (VHA) National Center for Patient Safety (NCPS) maintains a database of adverse events, Root Cause Analyses (RCAs), and Aggregated Reviews conducted by teams at VHA medical centers. For each RCA or Aggregated Review, an inter-professional team investigated the event, determined root causes and contributing factors, and recommended actions intended to prevent the occurrence of similar events in the future.

To better understand how VHA facilities have used standardization in response to adverse events, we searched the database for action items that included forms of “standard” or “standardize.” We used PolyAnalyst, a natural language processing program, to study the resulting RCAs and action items, exploring patterns in the types of things that were standardized.

Results
We identified 13,456 actions from approximately 6,000 RCAs and 2,000 Aggregated Reviews that used a form of the word “standard.” By examining the action items through interactive classification and taxonomic models generated using text clustering algorithms, we identified some common trends.

One area where standardization was frequently proposed was components related to the electronic health record (EHR). Examples included standardizing medication orders, infusion set orders, and templates. This level of standardization could occur at the facility level or nationally.

Equipment was another area where RCA teams proposed standardization. This was sometimes done in the format of standardizing the type of equipment used in the facility or within a particular unit. Some actions also called for standardizing settings on equipment.

Some actions called for standardizing processes such as the admissions process or the communication tool used for the hand-off process. Other common areas of standardization were specimen labels and contact lists.

Standardization was also used in actions that discussed training. In some cases, facility staff developed a plan to educate staff on existing standardized processes. In other cases, they attempted to standardize the training itself.

The language related to standardization also identified some care areas that were commonly mentioned in calls for standardization. The top areas were nursing, inpatient, primary care, and pharmacy.

Discussion
Timmermans & Epstein (2010) described four areas of standards: design standards, terminological standards, performance standards, and procedural standards. We were able to identify actions from RCAs relevant to all four of these areas. Equipment standardization creates a design standard for what can be used in a medical facility. Many of the actions related to the EHR and labeling redesign address terminological standards or finding common language. Some actions addressed the review of existing performance standards or the development of new ones. Attempts to standardize hand-off tools and check-in procedures are examples of creating procedural standards.

It is important to understand the current state of a system before attempting to impose some form of standardization. Standardization may already exist in a way that works for the users; it may simply not be formally documented. Even if it becomes clear that standardization is necessary and desirable, innovations or changes that do not fit with existing workflows or a reasonable adaptation in the workflow will be resisted by many end users. Changes may not be implemented at all or they may be implemented on paper while users in practice engage in frequent workarounds, giving the appearance of standardized work without the actual benefits of standardization. This could potentially be more dangerous than the previous state, because it increases the gap between work as imagined and work as done, making it more difficult to fully understand the current state.

Engineers and systems thinkers in general often like to have all aspects of a system clearly specified . Almost as soon as you document, however, a system will begin to grow and change. We should consider how we can encourage flexibility and resilience while still providing a reasonably accurate view of the current state to promote understanding from those outside the immediate system. Documentation should be complete enough to direct people where to look to understand the current state while at the same time acknowledging that the space will continue to change and that the documentation is just a snapshot of what exists now. This level of documentation should help people make informed changes or additions, especially regarding standardization of components within the healthcare system.

References
Berwick, D. M. (1991). Controlling variation in health care: a consultation from Walter Shewhart. Medical care, 29(12), 1212-1225.
Fuller, HJA & Arnold, T. (2021). The Flip Side of the Coin: Potential Hazards Associated with Standardization in Healthcare. In International Conference on Applied Human Factors and Ergonomics. Springer, Cham (2021).
NCPS. (2013). Primary Analysis and Categorization (PAC) Glossary Keyword Categories and Rules for Applying Them.
Perrow, C. (1967). A framework for the comparative analysis of organizations. American sociological review, 194-208.
Reason, J. (1997). Managing the risks of organizational accidents. Aldershot, UK: Ashgate Publishing Co.
Timmermans, S., & Epstein, S. (2010). A world of standards but not a standard world: Toward a sociology of standards and standardization. Annual review of Sociology, 36, 69-89.
VA Memorandum. (May 16, 2019). “High Reliability Organization—Lean Improvement Methodology.”
Wears, R. L. (2015). Standardisation and its discontents. Cognition, technology & work, 17(1), 89-94.