Lean Thinking For CSTDs

Lean management principles have been used effectively in manufacturing scenarios for decades, particularly in Japan. More recently, the use of Lean concepts in health care¹ has caught the interest of regulators, who suggest that the discipline be a guide for training pharmacists who are involved in pharmacy compounding procedures. One of those procedures—the use of closed system drug transfer devices (CSTDs)—may well be an under-recognized area for Lean applications.

The first step is to understand the basics of Lean management principles. Lean thinking begins by driving out waste so that all work adds value and serves customers’ needs. Identifying value-added and non–value-added steps in every process is the beginning of the Lean initiative. More specifically, Lean thinking comprises five principles: 1) defining value, 2) mapping the value stream, 3) creating flow, 4) using a pull system and 5) pursuing perfection.²

Too often in our everyday work in health care, we don’t really think about these principles as we make decisions about technology or design work processes. Often, consideration for things such as value stream mapping only happens once something has broken and needs repair. But the application of Lean principles should be a consideration on the “front end” of technology selection and process design and should periodically be reevaluated for all key processes.

By dismissing Lean principles, health systems lose the opportunity to benefit from its tool kit of efficiencies, consistency, safety and waste reduction. Also lost is the opportunity to improve complex processes while delivering substantial gains to the bottom line.³

Given those benefits, it’s not surprising that the use of Lean concepts in health care has caught the interest of the Massachusetts Board of Registration in Pharmacy, which has published “An Introduction and Guide to the Practices and Implementation of Lean Concepts in a Pharmacy Setting.” The document notes that “sterile compounding, complex non-sterile compounding, and institutional sterile compounding pharmacies shall ensure their employees are trained in lean concepts before renewing their pharmacy license.”⁴

Making the Initial Assessment

Since the introduction of the first CSTD to the U.S. market in 1998, many new CSTDs have emerged, providing organizations with a variety of options that best fit their compounding and drug administration processes (Table). Preferred features of a CSTD, based on general Lean principles, would include intuitive connections, pre-bonded components to limit the number of attachment/disconnection steps, pre-purging displacement air into the system, wetting potential of filters, and locking mechanisms that clearly indicate complete connection. In addition, systems also should limit the pressure required to engage and disengage the components, thus reducing the risk for repetitive stress injuries. The risk for repetitive motion injuries is a concerning yet underappreciated issue with drug compounding.⁵

Each device is very unique in the number of components, component options, mechanism of protection, integration with existing systems and costs, and, thus, should be assessed individually as a system versus generically categorizing the devices as a “CSTD.” The overall effect of integrating any device into medication safety systems must consider each end user’s use of the device(s), standard operating procedures, primary engineering controls, infusion pumps, disposal, staff perception of safety, number of components and overall costs.

Another factor to consider is the FDA’s clearance code for CSTDs, “ONB.” The code is applied to devices that have indications for use with antineoplastic and other hazardous drugs. Regardless of their technology, all devices cleared by the FDA under the ONB code are considered CSTDs.

Lean Attributes of CSTDs

Within updated USP Chapter <800> standards⁶ and nursing and pharmacy guidelines, the introduction of CSTDs was mandated for antineoplastic drug administration and recommended for compounding of hazardous drugs. In deciding which CSTD to deploy and how to effectively integrate a CSTD into compounding and administration processes, it is useful to think about these processes in the context of the five Lean principles.

1. Defining Value

Value at the simplest level is the quality delivered plus the customer satisfaction at a defined cost. It is imperative for a new technology such as a CSTD to meet the actual needs of the users. To select the optimal product and integrate that most effectively and efficiently into pharmacy and nursing practices, end-users have to clearly understand what they want and the price they can afford. For a CSTD, this can be challenging because the technology has two main user groups in nursing and pharmacy, both of which come with different needs and elements driving satisfaction. The primary value proposition for both health care professionals in regard to choosing a CSTD is protection—for their patients and for themselves. Compounding and administering medications require diligence in balancing timeliness and expected attributes while ensuring safety from needlesticks and exposure to hazardous drugs.

2. Mapping the Value Stream

In value stream or process mapping, the goal is to use the customer’s defined value as the desired end point and then to identify and map all the activities in the processes that contribute to these values. Activities that do not add value to the end user would be identified as waste. The waste can be further delineated into two categories: non-value added but necessary and non-value added and unnecessary. The first category should be reduced as much as possible, and the second category is just pure waste and should be eliminated to the maximum extent possible.

By reducing and eliminating unnecessary processes or steps in compounding and administration, including the steps for CSTD application, users can improve the likelihood that they are getting exactly what they want while reducing their costs. In compounding, eliminating the concern for possible needlesticks, over-pressurized drug vials resulting in spills/sprays, and lapses in aseptic technique due to individual variations with the use of traditional compounding tools (ie, syringe in combination with a needle) are non-valued waste that may be eliminated by a CSTD.

3. Creating Flow

After reducing wastes from the value stream, the next consideration is to ensure that the flow of the remaining implementation steps runs smoothly, without interruptions or delays. From the moment a CSTD is integrated from the vial, it is in a system of “flow” from compounding, to delivery, to administration and, finally, to disposal. Health systems that employ CSTDs minimize angst by not having to worry about needlesticks, drug vaporous sprays, lapses in aseptic technique and Luer line disconnections and spills, which can lead to delays in therapy and loss of revenue.

Further aiding flow, almost all CSTD manufacturers make options that allow connecting integrated CSTD tubing with the IV bag. When these direct spikes are used in compounding, they eliminate the need to prime tubing in the biological safety cabinet. This not only frees up pharmacy or technician time but also removes large, bulky items from the sterile compounding area. Examples of direct spikes can be seen in the Figure.

4. Establishing Pull

Inventory is considered one of the biggest wastes in any production system. The goal of a pull-based system is to limit inventory and work-in-process items while ensuring that the requisite materials and information are available for a smooth workflow. The uniqueness of each CSTD brings a significant variation in the number of components required for use. It is important to understand each component of CSTD systems to determine which components are required for a site’s medication management processes. Value stream mapping is a valuable tool to visualize the number of steps requiring CSTD components and which components are required. If you do not have all required components, this will result in delays, frustrations and safety issues. The importance of nursing and pharmacy defining the specific CSTD components and putting them together helps to understand what works for a particular site.

5. Pursuing Perfection

Waste is prevented or minimized through the achievement of the first four Lean steps. The fifth step of pursuing perfection makes Lean thinking a continuous process improvement endeavor. Pharmacy and nursing should actively promote and encourage continuous learning. As such, they always should look to find ways to use CSTDs to make the process of hazardous drug compounding and administration safer, more efficient and more cost-effective.

Future application of CSTDs includes use outside of hazardous drugs handling, where the noted Lean advantages can be applied to all sterile compounding, and the application of the devices to minimize potential medication waste through drug vial optimization programs.⁷ As the individual devices continue to evolve and the demand for sterile compounding continues to increase, CSTDs can serve as tools for growth.

Standard Work

Another hallmark of Lean management is eliminating variations in practice that can lead to increased waste and decreased quality and safety. CSTD components are designed to be modular and integrated in such a way as to standardize a specified method of drug compounding and drug administration. In addition, a well-designed CSTD provides a safe method for flushing tubing after the drug has been administered.⁸ Since nurses do not have the benefit of working in the same type of contained, controlled environment associated with compounding, the proper use of CSTDs helps to prevent widespread environmental contamination in the patient care areas. In addition, the more intuitive a system is to use, the easier it is to lessen variances in compounding and to facilitate effective training.

The device that integrates into pharmacy and nursing practices with perceived protection from both disciplines is the ideal CSTD. Other Lean attributes to consider are devices with the least number of components, packaging, steps for user-to-device interfacing, steps for device-to-device interfacing and drug transfer. These attributes should be fully vetted and validated at each site to ensure the advertised benefits of a specific CSTD meet the expectations of the staff using the devices. Ultimately, a CSTD should meet the efficiency needs of pharmacy and nursing with the benefits of saving time, controlling costs, minimizing line items and training.

References

1. Going Lean in Health Care. IHI Innovation Series white paper. Institute for Healthcare Improvement; 2005.
2. Womack JP, Jones DT, Roos D. The Machine That Changed the World. Free Press; 2007.
3. Shaw G. The ‘Gemba walk’ and its role in compounding quality assurance. Pharmacy Practice News. June 25, 2020. Accessed March 16, 2021. bit.ly/3tsYxV0
4. The Commonwealth of Massachusetts; Executive Office of Health and Human Services; Department of Public Health; Bureau of Health Professional Licensure; Massachusetts Board of Registration in Pharmacy; Policy No. 2016-013: An Introduction and Guide to the Practices and Implementation of Lean Concepts in a Pharmacy Setting. August 2016. Accessed March 13, 2021. bit.ly/3luAl1F
5. Abbot L, Johnson T. Minimizing pain resulting from the repetitive nature of aseptic dispensing. Hosp Pharm. 2002;9:77-79.
6. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. Accessed April 6, 2021. www.usp.org/ compounding/ general-chapter-hazardous-drugs-handling-healthcare
7. Buckley B, Buckley J. Is drug vial optimization set to expire? Pharmacy Practice News. June 8, 2018. Accessed March 17, 2021. bit.ly/3qUg9aI
8. Polovich M, Olsen M. ONS Safe Handling of Hazardous Drugs. 3rd ed. Oncology Nursing Society; 2018.

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