Time to upgrade instrumentation in the clinical laboratory: What to consider?

A Request for Proposal (RFP) is an opportunity for clinical laboratories to assess and compare instrumentation vendor options that address current challenges while meeting future needs (1). Here are a few things to consider.

Identifying Gaps and Future Goals

An initial step for a successful RFP is recognizing the institution's current gaps and future goals with instrumentation (2). Common gaps may include maxed-out instrument capacity, increased downtime, prolonged service time, decreased turn-around-time (TAT), limited test menus, rising test volume, and labor-intensive workflows. Pinpointing these limitations enables stakeholders to focus on finding suitable solutions. In addition, if future goals include increasing test volume, repatriating send-out assays, and standardizing instruments and practices across the enterprise, then it will be important to opt for a system with scalable instruments, a comprehensive test menu, and easy-to-use middleware. Alignment with your team on many of these expectations will allow for informed decisions to select the best possible solutions.

Seeing Instrumentation In Person

Scientific conferences or demo trucks are great opportunities for laboratory teams and other key institutional stakeholders to see instrumentation. Otherwise, site visits or contacting other facilities with a similar test menu, test volume, and patient population are also invaluable approaches for grasping the true performance of the system(s) under consideration. This can allow for pertinent questions and real-time feedback from vendors or peers. In addition, anonymous surveys after these visits can be an excellent way to collect suggestions and engage less vocal team members (3).

Technical items to discuss during these engagements may include hands-on time for maintenance, preventative maintenance downtime, third-party connections, middleware flexibility, problematic assays, and mitigation strategies, as well as any operational issues like workflow bottlenecks, service experiences, and recent supply chain backlogs and reagent recalls. This can also be an opportune time to involve IT colleagues in evaluating IT requirements, as these often require sufficient lead time. Overall, this approach can lead to a thorough understanding of how the system operates in real-world scenarios and offers opportunities for any lessons learned.

Performing Simulation Analyses

Vendor partners should assist in designing an instrumentation layout that will fit the institution's long-term needs. This is done by making sure clear expectations are set, open communications are maintained, and institution-specific LIS data are used to simulate various scenarios of growth. The latter should provide insightful performance data on various TAT and system capacities under various test volume situations. Additionally, the simulation will help the vendor balance instrument test menus and workloads among the instrumentation to ensure the configurations are as efficient as possible. This information can then set resource expectations that are needed during the test verification and validation process. Furthermore, the vendor may provide a workflow analysis or an all-day workshop, which could identify workflow improvement opportunities typically through lean Six Sigma principles (4).

Evaluating Service and Support Packages

Service and support packages are paramount to consider when selecting new instrumentation. The laboratory and vendor should work together to identify key performance indicators (KPIs) for various items. Examples include instrument uptime and downtime, hotline waiting time, field service engineer dispatch time during normal working hours, weekends, and holidays, first call fixing rate, and ticket repair TAT. Also, alignment around dedicated service engineers and the likelihood of a nearby parts depot that is stocked with essential parts are important considerations. It is also important to discuss training (virtual or in person), technical support options for instruments and middleware, and escalation paths that will support the patient care testing needs of the facility.

In conclusion, a well-executed RFP process depends on a thorough understanding of current gaps, envisioning future goals, conducting comprehensive technical and operational evaluations, and actively involving stakeholders. These steps are pivotal for ensuring the selection of instrumentation that not only addresses immediate challenges but also aligns with long-term strategic plans. By adopting a thorough and collaborative approach, clinical laboratories can navigate the complexities of the process with confidence, ultimately paving the way for enhanced workflow, improved patient care, and sustained growth.

References

1. Stacy E. F. Melanson, Neal I. Lindeman, Petr Jarolim; Selecting Automation for the Clinical Chemistry Laboratory. Arch Pathol Lab Med 1 July 2007; 131 (7): 1063–1069. doi: https://doi.org/10.5858/2007-131-1063-SAFTCC
2. Shiembob, David. How can I justify a capital purchase? The Academy of Diagnostics & Laboratory Medicine's Scientific Shorts. JUL.4.2023. Available from: https://www.myadlm.org/science-and-research/scientific-shorts/2023/how-can-i-justify-a-capital-purchase#
3. Feldhammer, Matthew. Making a Choice We All Can Live With. How to engage staff and select an automated chemistry and immunochemistry platform. The Academy of Diagnostics & Laboratory Medicine's Clinical Laboratory News. SEP.1.2019. Available from: https://www.myadlm.org/cln/articles/2019/september/making-a-choice-we-all-can-live-with
4. Goleansixsigma. Available from: https://goleansixsigma.com/what-is-lean-six-sigma/