How to Start a Clinical Laboratory (Step-by-Step CLIA Guide)
Starting a clinical laboratory means obtaining a CLIA certificate matched to your test complexity, meeting state licensure, staffing qualified personnel under 42 CFR Part 493, validating your test methods, and passing inspection before you report patient results.
Whether you call it starting a clinical laboratory, opening a lab, or starting a blood test lab or blood testing business, the path is the same: set up the business, choose the CLIA certificate that matches your test complexity, get state licensure where required, build a compliant facility, staff it with personnel who meet 42 CFR Part 493, validate your methods, and pass inspection. This guide walks through each step in order. Sound Lab Consultants (SLC) is a nationwide laboratory consulting network that helps new labs in all 50 states.
Step 1: Set Up the Business Structure
Form the legal entity, obtain an EIN, and set up banking and insurance before you apply for anything, because the CLIA application (Form CMS-116) asks for the facility name, address, ownership, and tax identification. Decide early who will own the lab and who will refer to it: physician ownership and referral relationships raise Stark Law and Anti-Kickback questions that your healthcare attorney should review. Write a business plan that defines your clients (physician offices, clinics, employers, direct-to-consumer where your state allows it), payer mix, and the tests that will pay for the lab.
Step 2: Define the Test Menu and CLIA Complexity Tier
Every test is categorized by the FDA as waived, moderate complexity, or high complexity. Your highest-complexity test sets your CLIA certificate type and your personnel requirements:
Certificate of Waiver: waived tests only.
Certificate for Provider-Performed Microscopy (PPM): specified microscopy by a physician or midlevel practitioner, plus waived tests.
Certificate of Compliance: non-waived testing surveyed by the State Agency.
Certificate of Accreditation: non-waived testing inspected by a CMS-approved accreditor such as COLA, CAP, or The Joint Commission.
Most blood test labs (chemistry, hematology, immunoassay) run moderate-complexity analyzers; molecular, toxicology confirmation, and many laboratory-developed tests are high complexity. See CLIA certificate types and test complexity.
Step 3: File the CMS-116 and Get State Licenses
Submit Form CMS-116 to the CLIA State Agency for the state where the lab is located. You will need the laboratory director named, the certificate type, test volumes, and specialties. CMS bills the certificate fee after processing; since March 1, 2026 CMS has delivered fee coupons and certificates electronically and accepts payment through pay.gov (CMS paperless FAQ). Several states also require their own clinical laboratory license or personnel licensure, and New York and Washington run their own programs in place of CLIA certification for most labs. Out-of-state specimens can trigger additional state permits. Our step-by-step CMS-116 application guide covers the details.
Step 4: Prepare the Facility
Choose space that fits the analyzers' electrical, plumbing (reagent-grade water, sinks, drains), HVAC, and temperature requirements, with separation of clean and dirty areas, specimen receiving, and storage. Plan biohazard waste handling and OSHA requirements (Bloodborne Pathogens Standard, chemical hygiene, eyewash). Check zoning and certificate of occupancy before signing a lease.
Step 5: Select Equipment and an LIS
Pick analyzers to match the test menu and expected volume, and confirm each test's FDA complexity category before purchase. Compare buying, leasing, and reagent-rental agreements. Choose a laboratory information system (LIS) that interfaces with your analyzers and your clients' EHRs, prints compliant reports (42 CFR 493.1291), and supports billing.
Step 6: Hire Personnel Who Meet 42 CFR Part 493
CLIA personnel requirements depend on complexity:
Moderate complexity: laboratory director (42 CFR 493.1405), technical consultant (493.1411), clinical consultant (493.1417), testing personnel (493.1423).
High complexity: laboratory director (493.1443), technical supervisor (493.1449), clinical consultant (493.1455), general supervisor (493.1461), testing personnel (493.1489).
The director is legally responsible for the lab's overall operation. Many startups use a part-time or remote-qualified director and technical consultant instead of full-time hires. See CLIA personnel qualifications and our laboratory director services.
Step 7: Validate Methods and Build the Quality System
Before you report patient results on an unmodified FDA-approved or cleared non-waived test, you must verify accuracy, precision, reportable range, and reference intervals (42 CFR 493.1253). Modified tests and laboratory-developed tests need full validation, including analytical sensitivity and specificity. Write the SOP manual, QC plan, competency assessment program, and specimen handling procedures, and enroll in proficiency testing for regulated analytes.
Step 8: Choose Accreditation and Pass Inspection
Non-waived labs are surveyed before full certification and then on a two-year cycle, either by the State Agency (Certificate of Compliance) or by an accreditor (Certificate of Accreditation). Compare options in COLA vs CAP vs Joint Commission, or see our COLA laboratory consultant and CAP laboratory consultant pages. A mock inspection before the real one catches missing records, competency gaps, and QC issues.
Step 9: Plan a Realistic Timeline
The order matters more than the calendar: entity and space, then the CMS-116 and state license applications, then equipment install and validation, then proficiency testing enrollment and inspection. Timing depends on your state agency's processing, accreditor scheduling, equipment delivery, and how quickly you secure a qualified director. Waived-only labs move fastest; high-complexity and multi-state labs take longest. We'll build a dated timeline for your state on a free consultation.
Step 10: Budget the Cost
Federal CLIA fees are public; most other costs depend on your menu, space, staffing, and equipment model (purchase, lease, or reagent rental). Build your budget around the test menu you chose in Step 2.
How Sound Lab Consultants Helps
SLC handles CLIA, COLA, and CAP compliance; laboratory director and technical consultant services; CMS-116 and state license filings; method validation; and inspection readiness for new labs in all 50 states.
Frequently Asked Questions
How do I start a clinical laboratory?
Form the business, choose your test menu and CLIA complexity tier, file Form CMS-116 and any state license, prepare a compliant facility, buy equipment and an LIS, hire a qualified laboratory director and staff under 42 CFR Part 493, validate methods, enroll in proficiency testing, and pass your CLIA or accreditation inspection.
How do I start a blood test lab or blood testing business?
A blood testing lab follows the same steps as any clinical lab. Most chemistry and hematology analyzers are moderate complexity, so you will typically need a Certificate of Compliance or Certificate of Accreditation, a qualified laboratory director and technical consultant, method verification, and proficiency testing.
Do I need a CLIA certificate to open a lab?
Yes. CLIA applies to any facility testing human specimens for diagnosis, prevention, treatment, or health assessment, including waived tests. Labs in New York and Washington are generally regulated by those states' own programs instead.
Who can be the laboratory director of a new lab?
It depends on complexity. Moderate-complexity directors must meet 42 CFR 493.1405 and high-complexity directors 42 CFR 493.1443. Requirements include specific degrees, board certification or experience, and in some states a state license.
Do I need COLA or CAP accreditation?
No. Non-waived labs can choose a Certificate of Compliance (state survey) or a Certificate of Accreditation from a CMS-approved accreditor such as COLA, CAP, or The Joint Commission.
How long does it take to open a clinical lab?
It depends on state agency processing, accreditor scheduling, equipment delivery, validation, and director availability. Waived labs are quickest; high-complexity labs take longest.
More SLC services: CLIA consultant, laboratory director services, laboratory consulting company.
Mailing address: Sound Lab Consultants, PO Box 2135, Chandler, AZ 85244.