Lab Startup Program
The lab startup program goal is to create price transparency for startup labs. Allowing the lab to budget the cost needed to meet CLIA requirements for waived and non-waived testing.
100% of laboratories enrolled in the startup program now generate revenue.
The Startup Consultation program for entrepreneurs who are interested in having their business model review and to understand various aspects of operating a laboratory. The initial consultation is $500 covers 2 hours of work. It covers topics including:
CLIA, CMS and State regulations
FDA - including EUA and LDT
Mobile/Temporary sites testing
OSHA and safety regulations
Insurance, billing, ICD-10, CPT code and reimbursement
The Waived Lab Startup program is designed for physician/dental offices, pharmacies and mobile lab wanting to offer waived testing and specimen collection service including urine drug screen. This program can also be used by companies and schools want to do health clinic. The program cost start at $750.
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. The program being used by labs that performed: COVID testing, lab developed test (LDT), urgent care center, physician's office, Nest Generation Sequencing (NGS) and toxicology lab.
Starting at $15,000 the basic services includes:
Services with additional charge:
100% of laboratories enrolled in the startup program now generate revenue.
The Startup Consultation program for entrepreneurs who are interested in having their business model review and to understand various aspects of operating a laboratory. The initial consultation is $500 covers 2 hours of work. It covers topics including:
CLIA, CMS and State regulations
FDA - including EUA and LDT
Mobile/Temporary sites testing
OSHA and safety regulations
Insurance, billing, ICD-10, CPT code and reimbursement
The Waived Lab Startup program is designed for physician/dental offices, pharmacies and mobile lab wanting to offer waived testing and specimen collection service including urine drug screen. This program can also be used by companies and schools want to do health clinic. The program cost start at $750.
- 5 hours of consulting time
- Completion of CMS-116 form
- Completion of any state application forms (Additional charge may apply)
- Testing procedure and training checklist
- Testing and quality control documents
- OSHA Bloodborne Pathogens procedure
- Secure 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)
- Website design - graphic designer to build out a website (Additional charge)
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. The program being used by labs that performed: COVID testing, lab developed test (LDT), urgent care center, physician's office, Nest Generation Sequencing (NGS) and toxicology lab.
Starting at $15,000 the basic services includes:
- 5 hours of consulting time
- Completion of CMS-116 form
- Completion of any state application forms (Additional charge may apply)
- Enrollment of approved proficiency testing
- 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
- Agreement template for CLIA lab director
- Provided customized procedures/forms/checklists to meet CLIA requirements
- Facility
- Fire Safety including: Fire safety checklist and fire drill log
- Safety manual covering engineering control, PPE, noise level and chemical hygiene, hazard communication and safety training checklist
- Biohazard/waste management
- OSHA Blood borne pathogens standard, including: OSHA job classification, sharp injury log, training checklist and hepatitis B vaccination
- Quality
- 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)
- Record retention
- Facility
Services with additional charge:
- CLIA personnel placement (Director, Clinical Consultant, Technical Supervisor and Technical Consultant)
- Completion of State application as needed (Cost varies depending on the state)
- Procedures for LIS/LIMS operation and LIS/LIMS validation
- Customized specimen collection procedures for on-site collection (COVID-19 PCR and antibody)