Lab Startup Program
Lab Startup Program
Our Lab Startup Program is designed to create price transparency for startup laboratories, enabling them to effectively budget for the costs associated with meeting CLIA requirements for both waived and non-waived testing.
The Startup Consultation Program
The Startup Consultation Program is designed for entrepreneurs and university incubators seeking expert guidance on operating a laboratory and a comprehensive review of their business model. With venture capital and investment banks tightening funding criteria, startups must now present detailed business plans and timelines to secure financing. This program provides valuable insights and tools that startups can use to develop budgets and timelines for investor presentations.
Fee: $2,500 (covers two hours of consultation and Q&A)
Format:
Tailored for startups in incubators aiming to secure funding, this program helps estimate timelines and budgets critical for investor proposals. Past clients include top university incubators from California, Louisiana, New York, and Pennsylvania. Areas of expertise addressed in previous projects include AI, bioinformatics, digital pathology, cancer detection, minimal residual disease, and sequencing.
Topics Covered:
Waived Lab Startup Program
The Waived Lab Startup Program caters to physician/dental offices, pharmacies, and mobile labs looking to offer waived testing and specimen collection services, such as urine drug screening. This program is also suitable for companies and schools interested in establishing health clinics.
Program costs start at $1,000 and include:
Non-Waived (Moderate and High Complexity) Lab Startup Program
This program simplifies and expedites the startup process for moderate- and high-complexity laboratories, following guidelines from the College of American Pathologists (CAP) and Clinical & Laboratory Standards Institute (CLSI). It is suitable for labs offering services such as COVID testing, Lab Developed Tests (LDTs), urgent care testing, Next Generation Sequencing (NGS), and toxicology testing.
Starting at $15,000, the basic package includes:
Our Lab Startup Program is designed to create price transparency for startup laboratories, enabling them to effectively budget for the costs associated with meeting CLIA requirements for both waived and non-waived testing.
The Startup Consultation Program
The Startup Consultation Program is designed for entrepreneurs and university incubators seeking expert guidance on operating a laboratory and a comprehensive review of their business model. With venture capital and investment banks tightening funding criteria, startups must now present detailed business plans and timelines to secure financing. This program provides valuable insights and tools that startups can use to develop budgets and timelines for investor presentations.
Fee: $2,500 (covers two hours of consultation and Q&A)
Format:
- Initial Presentation: Overview of key requirements and processes.
- Follow-Up Presentation: Answers to questions and additional guidance.
Tailored for startups in incubators aiming to secure funding, this program helps estimate timelines and budgets critical for investor proposals. Past clients include top university incubators from California, Louisiana, New York, and Pennsylvania. Areas of expertise addressed in previous projects include AI, bioinformatics, digital pathology, cancer detection, minimal residual disease, and sequencing.
Topics Covered:
- CLIA startup
- State laboratory licensure
- Out-of-state licensure
- Laboratory accreditation
- Lab-developed test (LDT) validation
- CLIA/Accreditation agency inspection readiness
- Line-item sample budget
- Gantt chart sample timeline
Waived Lab Startup Program
The Waived Lab Startup Program caters to physician/dental offices, pharmacies, and mobile labs looking to offer waived testing and specimen collection services, such as urine drug screening. This program is also suitable for companies and schools interested in establishing health clinics.
Program costs start at $1,000 and include:
- Completion of the CMS-116 form
- Completion of state application forms (additional charges may apply)
- Testing procedures and training checklists
- Testing and quality control documentation
- OSHA Bloodborne Pathogens procedures
- Assistance in securing testing supplies
- Protocols for off-site testing (mobile labs only)
- Temporary site checklist and off-site safety procedures (mobile labs only)
- Optional website design by a professional graphic designer (additional charges apply)
Non-Waived (Moderate and High Complexity) Lab Startup Program
This program simplifies and expedites the startup process for moderate- and high-complexity laboratories, following guidelines from the College of American Pathologists (CAP) and Clinical & Laboratory Standards Institute (CLSI). It is suitable for labs offering services such as COVID testing, Lab Developed Tests (LDTs), urgent care testing, Next Generation Sequencing (NGS), and toxicology testing.
Starting at $15,000, the basic package includes:
- 5 hours of consulting time
- Completion of the CMS-116 and CMS-209 form
- Completion of state application forms (additional charges may apply)
- Enrollment in approved proficiency testing programs
- Assistance with selecting LIMS/LIS vendors and billing software
- Performance verification in compliance with CLIA standards, including LDTs
- Job descriptions for testing and non-testing personnel
- Agreement templates for CLIA lab directors
- Customized procedures, forms, and checklists to meet CLIA requirements
- Fire safety (checklists, fire drill logs)
- Comprehensive safety manual covering engineering controls, PPE, noise levels, chemical hygiene, hazard communication, and training
- General laboratory systems: confidentiality, specimen identification, complaint investigation, communication, competency, proficiency testing, and quality management
- Pre-analytical processes: test requisition forms, specimen handling, referral procedures, and quality management
- Analytical processes: quality control, result comparison, corrective actions, and analytical quality management
- Post-analytical processes: test reporting and quality management
- Record retention policies
- CLIA personnel placement (Director, Clinical Consultant, Technical Supervisor, and Technical Consultant)
- Completion of state-specific applications (cost varies by state)
- Procedures for LIS/LIMS operations and validation