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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. Billable hours 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.
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I was asked if it was too late to start up a molecular COVID lab with the vaccine under review by the FDA and existing labs being more prepared for higher volume. The answer is no, there is still time to start up a molecular COVID lab to recoup the startup cost and be profitable. There are advantages for labs that are starting up now.
Starting a business is fraught with risks and especially in times of uncertainty like a pandemic. On the other hand, uncertainty also creates significantly more reward opportunities for those willing to take on the risk. At CLIA Lab Consultant we go beyond ensuring your lab is compliant with all regulations, but also for financial viability as well. In the past few weeks, we have been getting phone calls daily on how to start up Temporary Sites/Mobile COVID testing lab. The popularity of Temporary Sites/Mobile testing is driven by the increasing number of FDA EUA point of care testing options and the need to improve access to COVID-19 testing especially for return to work and safe reopening. Here are some advantages in starting up Temporary Sites/Mobile COVID testing labs.
Startup: We had helped labs obtain CLIA certification and complete setup Temporary Sites/Mobile COVID testing lab in less than one week. Supplies: Testing supplies can be obtained within 1-2 week. We had contact with distributors that can help your lab, obtain both waived antigen and antibody test kit. Reimbursement: We had helped labs gaining access to reimbursement through government programs and private insurances. The holiday season and the rising case of COVID-19 had increased demand for testing, which created opportunities for Temporary Sites/Mobile COVID labs. But the window of opportunity to COVID-19 testing lab is not going to be here for long, the COVID-19 vaccine has been submitted for FDA EUA approval and the recent FDA approval of at home COVID-19 testing means likely the mobile testing market would only be demanded until around spring/summer of next year. If you are an entrepreneur wanting to tackle the COVID-19 crisis, give us a call 909-294-8890 or email [email protected] for a consultation. |
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. Archives
April 2024
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