User:Shawndouglas/sandbox/sublevel4

In addition to seeking vendor expertise in LIMS implementation, the lab should also consider what technical services and support the LIMS vendor provides. Can the vendor address the following aspects?

• Setup: All LIMSs require a certain amount of setup. This can range from simply adding users and their access levels, to a more complicated setting up of assays, results ranges and reports or managing the fields on particular screens. Setup is best accomplished by the vendor working side-by-side with your designated LIMS administrator(s) as a form of hands-on training. Configuration and customization are also important elements of system setup. A system that can readily be tailored to the lab’s needs from the start tends to have a longer life due to its adaptability.

• Migration: If your laboratory is already established, you have raw data, audit records, reports and other types of information that will need to be loaded into the new system. Data migration can be a tricky process depending on the state and formats of the data to be transferred. Cleaning that data and information (i.e., weeding out duplicates, errors, etc.) and putting it into a transferable format can be tedious and costly. An experienced LIMS vendor will be able to automate the process as much as possible. However, your lab may still want to ensure metadata is properly represented and consistent to prevent additional vendor effort and save on costs.

• Verification: Before a LIMS implementation can be deemed complete, it must be fully tested and accepted as working to an agreed upon specification. System verification should be used to check that each LIMS function and feature is to spec and bug-free. This should occur throughout the implementation as each task is completed, and as part of final user acceptance testing (UAT) of the fully-delivered LIMS. Additionally, a verification process before go-live should check that the system actually meets the needs of the lab and adheres to relevant standards like CLIA, HIPAA, ISO 15189 and ISO 9001.

• Training: A clinical LIMS is a highly complex system, managing many aspects of the clinical lab. No matter how user-friendly it is, users must be introduced to the LIMS's capabilities and become familiar with its operation. The vendor should provide appropriate training, as well as materials like manuals and videos that can be used to train other employees going forward.

• Support: Post-implementation services can be divided into maintenance and warrantied work, with maintenance representing requested work (e.g., updates and upgrades that support the growth and changes of your lab over time) and warrantied work being the covered resolution of any system faults. However, regardless of an agreed upon post-implementation maintenance and warranty plan, the vendor should also provide some included level of support through the LIMS’ launch and for a reasonable period thereafter to ensure a smooth transition.

• Cloud and security services: Labs are increasingly finding value in moving informatics infrastructure and security requirements to a third-party. A LIMS vendor with veteran experience working with cloud infrastructures and security as a service provides more than a few benefits to the informatics-driven laboratory. With solutions in the cloud, for example, there is less of a need to address every user workstation every time there is a minor update, fix or upgrade since workstations access the LIMS via a web browser. Cloud can also provide valuable scalability, reduced responsibility and lower operational costs to labs. Labs can also inherit the security strengths (and weaknesses) of cloud vendors and their related services. Of course, the lab is not completely removed from security responsibilities (as seen with the shared responsibility models of many cloud providers) and must take a strong cybersecurity stance even when its informatics solutions are in the cloud. An experienced vendor can successfully guide a clinical lab towards best-practice use of cloud computing and security, and assist the lab in meeting its cybersecurity goals.