When I get calls regarding COVID lab startup, people will ask about the time it takes to get the lab up and running. They usually ask about reagent, analyzer, Biosafety cabinet (BSC), space requirement, etc., but often no one asks about LIMS/LIS initially.
Most labs would be going with a cloud-based system as it offers faster implementation and does not require on-site IT support. A google search on cloud-based LIMS will turn up a huge selection of vendors. Many of the cloud-based LIMS/LIS will appear very similar in terms of functionalities; it is often difficult for labs to evaluate which system is better based on demo and promotional material.
Clinical vs industry system
Some LIMS started in other industries (agriculture, cannabis, chemical processing, environmental, food/beverage and manufacturing) before entering clinical. It is important to know that healthcare and clinical labs are unique, repackage LIMS from other industries and selling it to clinical labs is not going to be a good system.
For COVID lab startup some basic LIMS function requirements include interfacing with molecular analyzers, physician/patient portal and reportable disease reporting to the public health department using HL7 and/or CSV files. Have the LIMS vendor provide the billable hours needed for each function ahead of time, if the LIMS vendor had experience in lab setup, they should not have a problem guaranteeing the hours needed.
Get reference: be specific and ask questions
Always ask for a couple references to contact and be specific, if setting up a high complexity COVID-19 PCR lab with multiple interfaces, patient/physician portal and HL7 public health reporting, ask the LIMS vendor to provide references that are using the same functionality.
As part of CLIA lab startup service, we would assist the lab in selecting the right LIMS and participate in conference calls with the LIMS vendor as needed, there is no additional charge for this service. As we recognize LIMS implementation is an integral part of the startup process and it is in the best interest of the laboratory to have an experienced lab consultant that can provide guidance to the lab.
Michael Yu, MS, MBA, MLS(ASCP)
Michael is the founder and owner of CLIA Lab Consultant where he provides consultation to laboratories and companies world-wide for startup and lab regulations, reimbursement, and testing strategies.