Startup of a clinical laboratory
Startup of a clinical laboratory
The clinical laboratory start-up services help to start a clinical laboratory from scratch and includes but no limited to application for several regulatory bodies for state and federal licenses and permits, laboratory equipment purchase, laboratory operation set up, laboratory SOPs and procedure and guidance for reimbursement. The services provided under laboratory start up program includes:
- Application for CLIA (CMS 116 form), COLA, CAP, Medicare/Medicaid (CMS 855-B form), states license (California, New York, Maryland, Pennsylvania, New Jersey, and Rhode Island)
- Laboratory space design
- Laboratory Instrument purchase
- Supplies and reagents purchase.
- Laboratory manual
- General and technical SOPs
- Test menu selection
- Lab personnel
- Laboratory information system (LIS) set up
- Competency assessment of lab personnel
- Test requisition forms design
- Report forms design
- Internal QC program
- Proficiency testing set up
- Correlation (split) analysis
These services can be provided in a whole package or individually.