Change Management in Response to Preventable Tragedies
This bulletin outlines the changes made to an institution, and how they were implemented, following the occurrence of 2 never-events involving concentrated electrolytes being administered to pediatric patients. Steps taken include the following: recognizing the need for change, building a multidisciplinary team to guide change, developing strategies to reinforce change, communicating strategies to promote buy-in, anchoring the change in organizational policies and procedures, and incorporating continuous monitoring and assessment.
INTRODUCTION
In January 2019, ISMP Canada published a safety bulletin about 2 pediatric deaths related to the use of concentrated electrolyte solutions.1 One incident involved the inadvertent use of concentrated potassium phosphate solution to flush an intravenous line; the other involved a preparation error that resulted in the patient receiving 10 times the required amount of potassium chloride intravenously. Intravenous administration of a concentrated potassium solution (≥ 2 mmol/mL) is considered to be a pharmaceutical “never event”. “Never events” are defined as “patient safety incidents that result in serious patient harm or death, and that can be prevented by using organizational checks and balances.”1 The internal analysis that followed these incidents led to several key changes at the hospital involved. The current bulletin not only outlines key strategies that were used to effect this change, but also describes how those strategies were successfully implemented.
BACKGROUND
The risk of serious patient harm due to the inadvertent use of concentrated electrolyte solutions was recognized by ISMP Canada in 2002,2 and safeguards were incorporated into Accreditation Canada’s standards and Required Organizational Practices by 2008.3 In the hospital where the incidents occurred, concentrated electrolytes had been removed from ward stock in most patient care areas by 2010, and safeguards were put in place for situations in which concentrated electrolytes were needed. Over the years since then, prescribers individualized electrolyte dosing for specific patient populations, which led to an increased use of concentrated electrolyte solutions for dose preparation in patient care areas.
The 2 tragic deaths, which occurred in a context of increased use of concentrated electrolytes, prompted creation of an internal multidisciplinary team to analyze the incidents, identify potential contributing factors, and review previous safety work in this area. A key factor was found to be the prescribing of electrolyte solutions in concentrations that were not commercially available, which in turn necessitated custom extemporaneous compounding in patient care areas. Implementation of an approach to prevent recurrence of similar incidents is described below in the context of change management.
CHANGE MANAGEMENT
Change management can be defined as a strategic and systematic approach that supports people and their organizations in the successful adoption of planned change.4,5 There are many popular approaches to and models of change management, most of which incorporate similar key concepts. The decision to use one approach over another is specific to each organization and its particular needs.6
Lewin’s theory of planned change, developed in the 1940s, uses the simple analogy of changing the shape of a block of ice in 3 steps: unfreeze (understand that change is needed), change (initiate the process of change), and refreeze (establish a new status quo).7,8 Newer models of change management, such as Kotter’s 8-step change model,9 the ADKAR model,10 and the transtheoretical model,11 set out additional considerations for change.
The hospital took the following steps in response to the 2 preventable tragedies:
Recognized the need for change
It is important to raise awareness among staff members that change is needed.8,10 At this hospital, the 2 pediatric deaths related to use of concentrated potassium solutions generated a sense of urgency that system-level changes were needed to prevent recurrence.
Built a multidisciplinary team to guide change
A coalition of personnel representing different points of view should be convened to develop a clear vision for the change initiative.8-10 At this hospital, the Pharmacy and Therapeutics Committee, consisting of representatives from multiple health care professions, became the guiding coalition that developed strategies to improve patient safety in the context of intravenous potassium solutions.
Developed strategies to reinforce change
The vision for change must be made clear to everyone to enable the development and reinforcement of strategies for change.6 At this hospital, one of the key goals was to reduce individualized prescriptions for intravenous electrolyte solutions (which were necessitating the use of concentrated electrolyte solutions). Strategies developed to support this goal included targeting different aspects of the medication-use process and engaging multiple health care providers. For example, preprinted and computerized order sets were modified to support the safe prescribing of electrolytes by including alternatives to intravenous electrolytes for certain clinical situations.
Communicated strategies to promote buy-in
The involvement of direct care providers, as well as managers and administrators, contributes to staff empowerment and promotes buy-in for the change.6,9 Change strategies should include appropriate education and training for all those involved, to provide knowledge about new skills and processes and to foster staff members’ ability to implement them. At this hospital, the list of available standardized electrolyte solutions was distributed to prescribers.
Anchored the change in organizational policies and procedures
Change must be anchored within the organizational culture,8 and the new standard of practice must be sustained through regular reinforcement,6 which may include celebration of each successful step in the process of change. At this hospital, the anchor was the development and implementation of comprehensive policies and procedures to guide the appropriate prescribing, handling, and administration of electrolyte solutions.
Incorporated continuous monitoring and assessment
Continuous monitoring ensures that the change is maintained and continues to be beneficial.6 At this hospital, there is continuous evaluation, both as part of an audit program and by including an indicator on the hospital administration’s management dashboard. The Pharmacy and Therapeutics Committee has incorporated monitoring tools during its annual review of policies relating to the storage, prescription, preparation, and administration of electrolyte solutions. An example is a reduction in the use of vials of concentrated potassium solutions (Figure 1).

Figure 1. Quantity of vials of concentrated potassium solution used by a single institution over a 10-year period, following Accreditation Canada’s introduction of an official Required Organizational Practice regarding concentrated electrolyte solutions in 2008. The grey oval highlights anomalous high usage due to a shortage of an alternative potassium product. The red arrow represents the point when the 2 pediatric deaths related to use of concentrated potassium solutions1 prompted internal analysis and action.
CONCLUSION
The development of strategies and recommendations following analysis of an incident is an important step to decrease the risk of recurrence. The subsequent step of implementing recommended actions—change management—can be challenging because it often requires changes in practice and engagement from all those affected. Change management models can help organizational leaders to effectively manage and guide their staff members through these processes.
At the hospital where these incidents occurred, multiple strategies were undertaken to reduce the risk of patient harm from inadvertent administration of concentrated electrolytes. In addition to continuing to comply with Accreditation Canada’s Required Organizational Practices, this hospital recognized the importance of understanding the risks specific to their practice and developing strategies to address those risks. These strategies included, but were not limited to, removing concentrated electrolyte solutions from patient care areas and providing supports for the prescribing of available standardized electrolyte products. The hospital succeeded in implementing changes in practice through effective leadership, a common vision, and practical strategies.
Organizations must recognize that change is an ongoing process and that continuous evaluation and reinforcement of new strategies are required to sustain any change over the long term. ISMP Canada, with support from the Canadian Patient Safety Institute (CPSI) has developed a Medication Safety Self-Assessment (MSSA) specific to “never events” that can help hospitals identify and assess their gaps in safety and the opportunities for improvement and change.
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Funding support provided by Health Canada. The views expressed herein do not necessarily represent the views of Health Canada.

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