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:
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.
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.