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Practice Change: Closed System Transfer Devices

Paper Type: Free Assignment Study Level: University / Undergraduate
Wordcount: 3101 words Published: 26th May 2020

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The United States Pharmacopeia (USP) issued new standards called USP Chapter <800> Hazardous Drugs: Handling in the Healthcare Setting. There has been research over the past decades that demonstrates risks for unintentional exposure to hazardous drugs which can cause acute and chronic health events in the workers who handle these drugs (Eisenberg, 2018). This standard defines processes for minimizing exposure to hazardous drugs in the healthcare setting and enacts new requirements that broaden the scope of earlier regulations. These mandated standards are enforceable by each state board of pharmacy and the US Food and Drug Administration (The United States Pharmacopeial Convention, 2017). The changes need to be implemented by December 1, 2019, but Mayo Clinic Rochester chose to implement the changes on September 1st, 2019.  The largest change for Mayo Clinic Rochester was the implementation of a closed-system drug-transfer device (CSTD) for all the preparation and administration of chemotherapy drugs. A CSTD is a device that prohibits the transfer of contaminants, such as hazardous drugs or vapors outside the system (Eisenberg, 2018). For administrative purposes, it connects to the distal end of primary tubing during chemotherapy administration and prevents dripping at time of disconnection, which is a high source of hazardous drug exposure (Eisenberg, 2018). No device such as this had ever been used, thus preparing and implementing this change was a process that began about one year prior to planned implementation date.

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In May of 2018 it was determined that Mayo would comply with federal regulations by  January 1, 2019. A large task force was formed, which included nursing and pharmacy leadership and administration. Little concrete information was shared, but much was shared that it would be a positive change. , but in the summer months, there were 3 options for CSTD that were presented to staff and the three companies came, we looked at the devices, they taught us how they worked and then we were able to evaluate and vote on which device we would use. A device was chosen and plans were made to order supply and arrange staff education. For numerous reasons, none of the 3 choices actually worked out and the January start date was pushed back to May 2019. Further issues with the trailed devices persisted, and leadership chose a device on their own with a new implementation date of September  1, 2019.

On July 1st 2019, mandatory education modules were emailed to staff who handle hazardous drugs. The modules explained the practice changes and gave directions on the use of the CSTD. The modules consisted of slides, voice overs and videos. Opportunity to send any questions or concerns was given with an internal  email address that would go directly to the USP <800> implementation team. It was strongly encourage to finish all the mdocules as soon as possible, as complaince was mandaotry and Mayo Clinic was being mandated by the dfefaral govemrmebnt, There was also information on the risks of exposure and the consqeunces which could be birth defects, miscarriage and health events that did not appear for years. Updated and revised Medication Management policies were published. The standards now adhered to USP 800

One week prior to implementation of the supplier of the CSTD that would be used was sent to Mayo Clinic Rochester for hands on teaching sessions. The sessions occurred on all units that handle chemotherapy drugs and ample notification was given that the sessions would occur. Schedules of sessions were emailed out weeks in advance and daily reminders during the time period that the educator was there were also sent. Staff were given the opportunity to have hands on experience and ask questions. Implementation of the CSTD occured on September 1, 2019. There were daily email updates on how the implementation was going and issues that had occurred. A small issue was the way the drugs were sent up by the pharmacy, they no longer had a pad, and this was a practice change that was unexpected and the leadership team apologized for this. NO otehr issues were noted and implementation was successful and the devices have been used favorable reviews.


The three stage change management model.

One of the most popular models of change management is the force field model developed by Kurt Lewin.

It consists of three primary steps number one on freezing the current state. Number to completing a transformation to our moving toward a new state. Number three refreezing the new state. Each stage is discussed in detail in the following paragraphs

This model includes the learning process, the motivation process, in the process of collaboration. Considering the difficulties that change and Asher in, the change process requires a great deal of planning. The unfreezing stage entails preparing for the change to be implemented and usually begins when the leader is convinced that the timing is appropriate to affect the optimal outcome. Unfreezing the current state of the organization to allow change is the most difficult part of the change process. In this stage the leader must recognize that, although some forces are likely to support the transformation, many more are in place to resist it leaders typically encounter difficulty influencing the unfreezing process because the managers

Who report to them tend to be more concerned with the present than they are with long-term plans. The leader must overcome this challenge by not only encouraging employees to think differently about the future but also nudging them toward helping the organization shift away at conducts business to ensure a future viability.

The second stage of change, the movement towards transformation represents the actual shift to the types of change in behaviors and actions that need to be implemented in the organization. With any change that is long overdue, perseverance is required to complete the transformation successfully into the satisfaction of all stakeholders. The transformational leadership style seems to work best in the second stage and is particularly critical to achieving success in affecting the needed transformation.

The final stage of the change process, refreezing, involves hardwiring the change into the operational system. To successfully refreeze the process, the leader must rely on his communication skills to help the organizations employees both accept and adapt to all the changes. Staff are most likely changing years of habits I have probably worked well in the past. The leader must help employees embrace new behaviors and practices related to the change as the new way of conducting business. Furthermore, the leader is instrumental in helping all his staff Samantha newly change behaviors in their individual business model. Ways that he can assist in this effort include providing applicable and adequate training, resources, and in most cases incentives for employees to fully adopt the new behaviors.

Organizational change textbook

The first step is to unfreeze the present level of behavior. This stuff according to Luanne, can take many forms and needs to be tailored as much as possible to the particular situation. At the organizational level the unfreezing step could be one of presenting data to organization members that show a sizable gap between where they are and where they need to be to meet growing demand in their marketplace, for example, where customer service is slipping dramatically. The second step is to move toward the new desired level of behavior. In the organizational gap example moving might take the form of training managers to behave differently toward their subordinates to improve customer service or implementing action plans for changing work processes or improving information systems. The refreezing stuff establishes ways to make the new level of behavior relatively secure against change. This step could include installing a new reward system to reinforce the new desired behavior or restructuring certain aspects of the organization so new accountability arrangements and new ways of measuring performance are put into place.

Unfreezing: Creating motivation and readiness for change, disconfirmation or lack of confirmation. Demonstrate a need for change by, for example, servicing organizational members to satisfaction by showing that the customer base is he rolling in something must be done just on the tide. Demonstrate a need for change by, for example, servicing organizational members to satisfaction by showing that the customer base is eroding and something must be done just on the tide. Induction of guilt or anxiety. When organizational members are faced with data natural gap between what is and what would be better there likely to be motivated by guilt feelings and general anxiety to reduce the gap and to take action toward goals would make things better. Creation of psychological safety. Creating disconfirmation and adducing else and in Zaidi or not enough to accomplish everything. People must believe that doing so will not cause feelings of embarrassment humiliation passivate or self-esteem. Members need to feel worthy and psychologically safe, that is to have no fear of retribution or punishment for embracing the change.

Changing: Changing involves cognitive restructuring. Organizational members need to see things differently from how they saw them before and as a result of this different view must act differently. There must be identification with a new model, mentor, leader, or even a consultant to begin to see things from that other person’s point of view. We must scan the environment for new relevant information.

Refreezing: refreezing is the integration of the change for the organization members and has two parts. Personal and individual helping the organizational members feel comfortable with the new behavior that is required to make the change succeed, to make the new behavior with one self-concept. This process requires considerable practice, trying out the new behavior getting feedback and then being rewarded when one gets it right. Making sure that the new behavior fits well with others who are significant in the organization in other words if I change you’ll also need to change if we are working together effectively.

Abd El-Shafy, I., Zapke, J., Sargeant, D., Prince, J. M., & Christopherson, N. A. M. (2019). Decreased pediatric trauma length of stay and improved disposition with implementation of lewin’s change model. Journal of Trauma Nursing : The Official Journal of the Society of Trauma Nurses, 26(2), 84-88. doi:10.1097/JTN.0000000000000426

Successful change comes through the use of a plan approaching realizing change management framework. Kurt Lewin three step change model is a commonly use systematic approach focused on human resources and how they impact the change process. Lewis’s research into group behavior identified that an individual leader among the group needs to be with the present situation as being Sustained by forces and behaviors from within the group in order to initiate change. This individual is referred to as the change leader. We win stated that if you could identify these forces, you could not only identify the manner in which a person behaves but also identify the forces that would need to be targeted to bring about the change.

To impact these forces Lewin developed the three-step change model. First the group must go through and I’m freezing process for the current balance must be interrupted in order for a new process to be learnedBeyond freezing stuff is the most difficult of the change process. Once a change leader has been able to break the status quo the group is ready for what the wind refers to as the moving phase.

During the second phase the change late The unfreezing stuff is the most difficult of the change process. Change leader has been able to break the status quo the group is ready for what women refers to as the moving phase.. During the second phase the change leader must sees the motivation that has been created during the first stage and provide guidance to move the group toward the end goal. Having motivated the group toward the goal, further reinforcement is needed for sustainment.

The final stage is solidifying or refreezing. It is essential to prevent a group from reverting back to old behaviors. Through continued positive reinforcement the new status quo and effectively create a culture change.

First stage identifying the issues within the current practice requiring change, listening to and engaging involve providers, we started to break down the cultural barriers to change.

Kurt Lewin, a German-American psychologist, was known for his study of organizational development. He developed a model of change which he described as a three-stage process, known as Lewin’s theory of change (Burnes & Bargal, 2017).

He thought that changing people’s attitudes or behavior was only done by breaking a custom or social habits, which were often resistant to change. In order to overcome resistance to change, it is necessary to apply additional force that is able to break the habit or

“unfreeze” the habit (Burnes & Bangalore, 2017). His theory of change consisted of three stages, unfreezing, movement and refreezing.

Burnes: First level is unfreezing the present level of customs or habits, necessary to open the shell of complacency and self righteousness. Second stage is moving, when the change actually occurs and then refreezing, when the new habit the norm and adopted and institutionalized

Shirley: Unfreezing involves getting ready for change. This entails a change agent, such as a mandate. Or nurse leader recognizing a problem, identifying the need for change and mobilizing others to see the need for change. Unfreezing should create a sense of urgency, a solution is selected and preparation for change occurs.

In this stage identify the factors for and against change. Successful change necessitates strengthening the driving forces and or weakening the restraining forces.

Moving or transitioning the second stage entails looking at change as a process rather than an event. Transitioning is the individuals make in reaction to change and requires on freezing or moving 20 with me. This stage necessitates creating a detailed plan of action and engaging people to try out the proposed change. Often difficult because it has uncertainty and fear associated with the change. The transition stage involves coaching to overcome fears losing sight of the desired target which is a new improved reality

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Refreezing the third stage demand stabilizing the change so that it becomes embedded into existing systems such as culture politics and practice. And refreezing the change nurse leaders continue to accentuate the driving forces facilitating change in counteract the restraining forces or getting it in the way of the change. With refreezing the new change, this dynamic produces a new equilibrium which has been recognized as the new normal or higher level of performance expectation. The third stage is important because locking in or institutionalizing change will be crucial overtime

This theory is considered most effective when used in top down approach to change. Senior members of an organization and other formal leaders drive and support change.

Unfreezing: Holding town hall meetings with staff nurses to describe the anticipated needs. Nurse leaders should strengthen the driving forces and weaken the restraining forces, lewin’s model is best used in a highly stable environment, when there is time to implement changes. In a top down approach to change, the senior leaders are the champions driving the change.

Manchester: The Lewin anchors of altering a clinical path or approach (unfreezing), refining change and reinforcing

Unfreezing: new procedures and behaviors prompt disturbances to the status quo of an organization. This disequilibrium occurs as driving forces for change overcome resisting ones. The adoption of new protocols for practice. The changes or driving forces represent momentum which can be met with resistance, need staff buy in

Movement: once movement has begun, the organization allows for trial and error to occur and new social norms guide people toward the practices, attitudes may be favorable and resistance declines, there may reveal the need to improve education or provide clinical reminders, refinement of the process

Refreezing: existence of new practice has altered the organizational setting forcing it to accommodate socially and organizational, this is the point at which reinforcements will increase likelihood of sustaining them. The organization will revert to the status quo of it fails to acknowledge the normality of the behaviors, booster sessions, more education, etc. revisit challenges and planning for the next steps

Anticipation of a clinical practice change occurring brings about a learning event, to generate knowledge. This new event may bring about disequilibrium which could be a resistor or driver. Lack of  movement or momentum could be offset by having nurse champions to ensure proper movement


  • Burnes, B., & Bargal, D. (2017). Kurt lewin: 70 years on. Journal of Change Management, 17(2), 91-100. doi:10.1080/14697017.2017.1299371
  • Shirey, M. R. (2013). Lewin’s theory of planned change as a strategic resource. The Journal of Nursing Administration, 43(2), 69.
  • Manchester, J., Gray-Miceli, D. L., Metcalf, J. A., Paolini, C. A., Napier, A. H., Coogle, C. L., & Owens, M. G. (2014). Facilitating lewin’s change model with collaborative evaluation in promoting evidence based practices of health professionals. Evaluation and Program Planning, 47, 82-90. doi:10.1016/j.evalprogplan.2014.08.007
  • (The United States Pharmacopeial Convention, 2017)
  • Eisenberg, S. (2018). USP and strategies to promote hazardous drug safety. Journal of Infusion Nursing, 41(1), 12-23. DOI:10.1097/NAN.0000000000000257


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