Starting up new business ventures around COVID testing

​There are an increasing number of entrepreneurs wanting to start up new business ventures around COVID testing but without operating a lab. Some of the areas included: 

• Marketing 
• Supply chain
• Logistics
• IT/programming 
• Management services

Entrepreneurs usually feel very strongly about how their idea and business plan will work. Unfortunately, over 90% of the consultation calls involving business ideas that are illegal, some of the examples included:​

• Sharing/borrowing another lab CLIA license
• Advertising testing service without a CLIA license
• Advertising COVID test kit as their own company’s product when they are only a distributor 
• Obtaining CLIA for the purpose of specimen collection and referral testing only 
• Perform surveillance pool testing, but go back to individually test each sample without CLIA
• Applying for CLIA before the lab is set up
• Bypassing physician order requirements in state required order from a licensed provider
• Having untrained personnel performs collection and testing 
• Have patient self-collect nasal swab when the test had not been approved by FDA for self-collection
• Change the sample type from venipuncture whole blood to capillary blood when capillary blood sample isn’t listed as an acceptable sample type in the FDA approval

​I have worked with clients where the only reason they start looking for a lab consultant is because they received a cease-and-desist letter from CMS or a notice from FDA their company website contains misleading information. 
Hiring a lab consultant early on during the business planning process, not only can help entrepreneurs avoid legal actions by CMS, FDA, and State regulators. But an experienced lab consultant can provide valuable insight into the laboratory industry and help make connections.

At CLIA Lab Consultant, we provide startup consultation for $1,000 covering 2 hours of work, for the following topics: CLIA, CMS, State regulations (if applicable), FDA, EUA, Mobile/Temporary Site testing, OSHA, safety regulations, insurance, billing, ICD-10, CPT code and reimbursement.