Volume 38 Number 3 | June 2024
Theresa Summons, MHA, MLS(ASCP)CM, ASCLS Today Volunteer Contributor
Everything we do in the lab can be considered a project; but this is not how clinical laboratories traditionally think. Projects are often defined as a process to develop tangible products or solutions. In the clinical lab, we deal with such items as the daily QC and the release of patient results, more service than product. However, we can also deal with process improvements and assay validations, which are projects in nature and, as such, should be governed by a system to allow for proper tracking and documentation.
Quality and productivity improvement demands over the years have driven lab managers to find ways to optimize laboratory processes. With ongoing hearings and conversations about laboratory-developed test (LDT) oversight, clinical laboratories may have a looming demand for more stringent assay validations to accommodate possible FDA submissions. This can be overwhelming for labs that do not have the infrastructure to facilitate these types of demands. With staffing shortages and increased testing, labs are stretched thin as is. If we are struggling with normal day-to-day demands and future demands that are already in the pipeline, how can we now implement a project management process from scratch?
Project management in the clinical laboratory needs to support a clear representation of the environment, an accurate account of technical resources and staff availability, and an establishment of a collaborative interaction with hospital administration or ownership. To have a successful project management system, there needs to be buy-in from the top down. To facilitate the buy-in in my lab, I identified the specific areas where we would benefit from the addition of a formal project management system. We had been dealing with stagnant growth and projects that stretched out over years due to scope creep and lack of clear direction. After showing where we could make improvements and putting together a project management office (PMO) charter, we were ready to implement the process.
“With the uncertain future of how labs function in the LDT space and the ongoing need to improve lab quality in general, changing the mindset for a formalized project management process within the clinical laboratory is important and necessary.”
As it was a new idea for most of the team, we started with paper-based forms and documentation processes to ease the way. I found that after creating the foundation of a project management system, it was simple to improve upon it with both an electronic process and adjustments based on the needs of the organization. Since the signing of the charter in July of 2021, we have successfully completed 13 projects ranging from portals for shipping and vet results, to HL7 interfaces, to four new or modified assays for our test menu. All were completed with the expected deliverables and within a 10 percent variance on the initial timeline.
The idea of implementing a new system can seem daunting, but it can be accomplished in small steps, and the new system will allow you to drive your lab forward in any direction you wish.
- The first step is to define the environment and focus of the program. This can range from the physical space itself, to the type of shift-work dynamic, to management styles, or even to the autonomy of the lab within the organization.
- The next step is to consider technical resources and staff availability. Consider the type of software or document system that will be used to create the accountability needed for a successful program. Determine whether you have staff that can both perform their duties but still have time in the day to help with the project implementations. Not only is this an opportunity for professional development, but it also allows the team to have a stake in the functionality of the lab and it creates a sense of ownership.
- Finally, to build a successful project management program, there needs to be an interplay with hospital administration or company ownership. The upper management approval of the new process ensures that inevitable growing pains do not derail the end goal. Once the foundation of a project management program is established, the rest will fall in place as each project is executed and metrics are tracked.
The projects themselves are simple and can be done following the same pathway no matter the focus. For my organization, we are more than just a clinical la,b and we must have the ability to vary the project process depending on which type of project we are managing. I broke the types of projects into three categories: LDT, IVD, and other. LDT and IVD are the specific new or modified assays we offer, and the “other” category covers everything else from portals to a new phone system. All three follow the same pathway, just with different necessary tasks within their respective project plans.
If we look at a new or modified LDT assay, for example, the project pathway would start with an idea in R&D. Once initial feasibility shows promise, a proposal is created where we bring all the stakeholders to the table to discuss expectations and requirements. The assay design continues until we have a final feasibility that meets all the requirements, and then we are ready for design freeze. The project initiation form, which captures the feasibility, expected revenue, and FTEs needed for implementation, is then completed. In my organization, an LDT assay release starts with a validation of the manufacturing processes needed and ends with a rigorous validation of the product within the clinical lab before it is released to the market. At completion, we summarize the success or failure of the project in a closure report, and at that time we determine the metrics that we will use six months later to see if the product is trending as expected. The important aspect of the closure is the list of any shortfalls encountered and key lessons learned during the process to ensure better outcomes for future projects.
Overall, the introduction of a formal project management process helps reduce uncertainty, increases predictability, and drives growth. While growing pains are inevitable, and there may be a slight learning curve in the beginning, this new process helps an organization improve and grow. With the uncertain future of how labs function in the LDT space and the ongoing need to improve lab quality in general, changing the mindset for a formalized project management process within the clinical laboratory is important and necessary. I believe implementing a formal project management process is the best way to support future growth in the clinical laboratory space.
Theresa Summons is Operations Project Manager III at MiraVista Diagnostics in Indianapolis, Indiana.