Our lab startup program aims to provide aspiring researchers, scientists, and innovators with the necessary resources, support, and guidance to transform their ideas into impactful scientific discoveries and clinical laboratory testing. We will advise your entrepreneurial team on lab budgets and how to generate revenue. All of our laboratories enrolled are now generating revenue.

The Startup Consultation program for entrepreneurs and healthcare providers who are interested in having their clinical medical lab business plan reviewed. The initial consultation is $500 and covers 3 hours of work, the $500 can be credited toward any of our startup programs.

Our Lab Startup Consultation Program covers:

Understanding CLIA, CMS and State regulations
How to work with the FDA - including EUA and LDT
How to setup Mobile/Temporary sites testing
Complying with OSHA and safety regulations
Setting up insurance billing, ICD-10, CPT code and lab testing reimbursement

The Waived Lab Startup program is designed for healthcare professionals and entrepreneurs to run laboratory tests such as comprehensive metabolic panel, urine tests, stool tests, drug testing, cholesterol/lipid tests, and COVID-19 and/or antigen testing. We start labs for Urgent Care centers, Physician offices, toxicology labs, independent labs, mobile phlebotomy labs, drug addiction labs, freestanding emergency room labs, hospital labs, school labs, university clinical labs, and many more.

The total program cost is $3,000 for physician/dental offices, hospitals, and pharmacies.

$2,000 for all other lab types.

Our waived lab startup program includes:

• ​Completion of CMS-116 form (CLIA Certificate fees do not apply)

• 10 hours of consulting time

• Completion of any state application forms (State charges do not apply)

• Testing procedure and training checklist

• Testing and quality control documents

• OSHA Bloodborne Pathogens procedure

• Access to order testing supplies (COVID Antigen and Antibody test kits)

• Protocol for off-site testing (Mobile lab only)

• Temporary site checklist (Mobile lab only)

• Off-site safety procedure/checklist (Mobile lab only)

The Non-waived (Moderate and High complexity) Lab Startup program is designed to simplify and expedite the lab startup process with a set price. Procedures are written following College of American Pathologists (CAP), CLSI (Clinical & laboratory Standards Institute) guideline.

Our Non-waived moderate and high complexity lab startup program is being used by labs that perform COVID testing, lab developed tests (LDT), and Next Generation Sequencing (NGS). We start labs for Urgent Care centers, Physician offices, toxicology labs, independent labs, mobile phlebotomy labs, drug addiction labs, freestanding emergency room labs, hospital labs, school labs, university clinical labs, and many more.

​Starting at $18,000 Non-waived (Moderate and High complexity) Lab Startup program includes:

• 5 hours of consulting time

• ​Completion of CMS-116 form (Additional CLIA Certificate charges apply)

• Completion of any state application forms (Additional State charges apply)

• Enrollment of approved proficiency testing (Additional Proficiency charges apply)

• Selection of the LIMS/LIS Lab Information System Vendor

• Selection of billing software vendor and insurance enrollment, including Medicare

• Verify performance verification with CLIA standard - including Lab Developed Test (LDT)

• Job Description for both testing and non-testing personnel

• CLIA lab director Agreement template

• Full Standard Operating procedure (ABOUT 350 PAGES average) manual including forms and checklists to meet CLIA requirements

• Procedures for LIS/LIMS operation and LIS/LIMS validation

• Fire Safety

• Safety manual

• Biohazard/waste

• OSHA Blood borne pathogens

• Quality Control

  • General Laboratory system (confidentiality, specimen identification, complaint investigation, communication, competency, proficient testing and general lab quality management)

  • Pre-analytical (test requisition form, specimen submission/handling/referral and pre-analytical quality management)

  • Analytical (Quality Control, comparison of test result, corrective action and analytical quality management)

  • Post-analytical (Test report and post-analytical quality management)

Services with additional charges:

• CLIA personnel placement (Director, Clinical Consultant, Technical Supervisor and Technical Consultant)​

Entrepreneur Business Idea. Start A Medical Lab with our Lab Startup Program