CLIA · CAP · ISO 15189 · NY CLEP · State Licensure
From launching a new laboratory to preparing for your next inspection, our team brings decades of combined regulatory, technical, and operational expertise to every engagement.
About our consulting division
At ResearchDx, our Clinical Laboratory Consulting Division has earned a reputation as a premier partner for CLIA-licensed and CAP-accredited laboratories nationwide. Whether you’re launching a new laboratory, transitioning an assay from research to clinical use, or preparing for your next inspection, our team brings decades of combined regulatory, technical, and operational expertise to every engagement.
We deliver complete turnkey clinical laboratory startup services for organizations building from the ground up, and we work just as effectively alongside established laboratories — integrating only the specific components your current framework needs, without disrupting what’s already working.
Why ResearchDx
Decades of combined experience across CLIA, CAP, ISO 15189, and FDA regulatory frameworks
A track record supporting laboratories through initial licensure, expansions, and complex deficiency remediation
In-house scientific and bioinformatics depth — we understand the assays we help you commercialize, not just the paperwork behind them
Flexible engagement models: full turnkey buildout, interim staffing, or targeted project support
A single point of contact who coordinates regulatory, technical, and quality workstreams so nothing falls through the cracks
Who we serve
Launching a new CLIA-certified facility or expanding test menus.
Developing companion diagnostics or LDTs that require a compliant clinical lab pathway.
International laboratories and diagnostics companies seeking U.S. market entry through CLIA/CAP pathways.
Transitioning research-use assays into a clinical testing environment.
Regulatory roadmap
Three questions decide your compliance pathway: how complex your tests are, which CLIA certificate that requires, and which states’ rules apply.
The FDA categorizes tests as waived, moderate, or high complexity. Uncategorized tests, including most LDTs, are treated as high complexity.
Your most complex test determines which certificate you need. Every certificate is valid for two years and covers waived testing.
Where your lab operates — and where your specimens come from — can add state licenses on top of CLIA.
Five CLIA certificate types, grouped by the testing they cover.
Testing
Simple tests the FDA has determined carry a low risk of an incorrect result.
Certificate
Certificate of Waiver
Oversight
No routine inspections. Follow the manufacturer’s instructions; surveys occur only on complaint.
Testing
A limited list of moderate-complexity microscopy procedures (e.g., wet mounts, KOH preps) performed by a physician, midlevel practitioner, or dentist during the patient visit.
Certificate
Certificate for Provider-Performed Microscopy Procedures (PPM)
Oversight
No routine inspections; surveys occur only on complaint.
Testing
Most clinical testing, including molecular, NGS, and laboratory-developed tests.
Certificate
Certificate of Registration to begin testing, then either a Certificate of Compliance (surveyed by CMS or the state agency) or a Certificate of Accreditation (through a CMS-approved organization: CAP, COLA, The Joint Commission, A2LA, AABB, ASHI, or ACHC).
Oversight
Inspected every two years, with proficiency testing, qualified personnel, and a full quality system.
Moderate- and high-complexity labs choose how they demonstrate CLIA compliance. Both routes lead to a full CLIA certificate; they differ in who inspects you and against which standards.
Certificate of Registration — begin nonwaived testing while awaiting your first survey
↓ Then choose one route ↓
Who inspects
CMS or your state survey agency.
Standards
The federal CLIA regulations (42 CFR Part 493).
Frequency
Every two years.
Fees
CLIA certificate and survey fees, paid to CMS.
Often a fit for
Labs that need CLIA certification but no third-party accreditation from clients, partners, or payers.
Who inspects
A CMS-approved accreditation organization you choose — CAP, COLA, The Joint Commission, A2LA, AABB, ASHI, or ACHC — plus CMS validation surveys of a limited percentage of labs.
Standards
The accreditor’s requirements, which CMS approves as meeting or exceeding CLIA.
Frequency
Every two years.
Fees
CLIA certificate fees paid to CMS, plus the accreditor’s own fees.
Often a fit for
Labs supporting pharma clinical trials, international clients, or partners that expect CAP or similar accreditation.
The same either way: proficiency testing, qualified personnel, a documented quality system, and a CLIA certificate renewed every two years. ResearchDx supports both routes — from the application through inspection day and deficiency responses.
CLIA is the federal baseline. Some states replace it, and others add their own licenses on top.
New York (Clinical Laboratory Evaluation Program) and Washington (Medical Test Site Program) run CMS-approved state programs. Labs located there are licensed by the state in place of a CLIA certificate.
Several states may require their own clinical laboratory license in addition to a CLIA certificate including CA, CT, HI, IL, KY, ME, MD, MA, NV, NH, NJ, NY, PA, RI, TN, WA and DC
Accepting specimens from other jurisdictions can require licenses there too. New York, California, Pennsylvania, Maryland and Rhode Island license out-of-state laboratories that test specimens collected there.
State requirements as of October 2026; scope and exemptions vary by state (for example, many states exempt physician office or waived-only labs), and some states also license laboratory personnel. Florida (2018) and Georgia (2021) have repealed state laboratory licensure. Requirements change — we confirm the current federal and state rules for your test menu and specimen sources at the start of every engagement. Sources: CMS, How to Obtain a CLIA Certificate; CMS List of Exempt States; state health department regulations.
Lab startup & compliance
Whether you’re opening a new clinical laboratory or expanding an existing test menu, we handle licensure, personnel, documentation, validation, and inspection readiness — so your lab is built for compliance from day one.
Starting a new clinical lab, or need help with an existing one?
Start a discussionCLIA certificate and survey fees, accreditation fees, state licensure fees, and proficiency testing fees are paid directly to the issuing agencies and providers. Your laboratory is responsible for employing qualified testing personnel; ResearchDx can provide contracted directors and consultants.
Ways to engage
Bring us in for a single, well-defined engagement or for the full buildout. Every scope is tailored to your laboratory, test menu, and timeline.
A structured review of your laboratory against CLIA, CAP, ISO 15189, and applicable state requirements, delivered as a prioritized remediation plan.
A mock CLIA or accreditation inspection modeled on how inspectors work, with written findings and guidance on corrective actions before the real visit.
Responses to CLIA standard- and condition-level deficiencies and to CAP and ISO 15189 audit findings, plus support putting the corrections in place.
Contracted or interim Laboratory Directors and Clinical and Technical Consultants, along with evaluation of your director and personnel qualifications.
End-to-end buildout: quality management system, document control, SOPs and forms, validation support, onsite visits, mock audit, inspection-day support, and post-licensure follow-up.
Deficiency responses run on deadlines. Contact us as soon as you receive findings so we can help you prepare a complete, on-time response.
Virtual Clinical Laboratory
Custom and esoteric assays are our specialty. Run your test in our fully CLIA-licensed, CAP-accredited molecular laboratory without building your own.
A fully CLIA licensed and CAP accredited molecular clinical laboratory
A dedicated state-of-the-art laboratory information system
Access to state-of-the-art equipment and facilities
Dedicated laboratory space
A team of experienced California licensed, CLIA-qualified laboratory technologists
Extensive bioinformatics capabilities
Dedicated phone tree and client services
Customized reporting options available
Flexible billing
International
With extensive experience in licensure and accreditation, ResearchDx assists international companies to navigate the international certification and accreditation requirements for the United States Clinical Laboratory Improvement Amendments (CLIA) international certification process and the College of American Pathologists (CAP), where required. We also offer consulting services related to the ISO 15189 certification process.
Many pharmaceutical company clinical trials are requiring these internationally recognized standards, and the process is slightly different for international laboratories.
We uphold the standards of the federal government and use Good Laboratory Practices throughout the entire process. We can provide complete support for comprehensive startup services, or work with our client’s existing systems and integrate only the components needed for licensure and accreditation.
Regulatory landscape
CLIA certification, CAP accreditation, and (for laboratories serving New York) CLEP approval remain the governing compliance pathways for LDTs.
In 2024, the FDA finalized a rule asserting authority to regulate laboratory-developed tests (LDTs) as medical devices. That rule was vacated by a federal court in March 2025, and the FDA formally rescinded it in September 2025 — restoring the traditional regulatory framework in which LDTs are governed by CLIA and, where applicable, state programs like New York’s CLEP, rather than FDA premarket review.
There is no current FDA premarket submission requirement for tests developed and performed within a single CLIA-certified laboratory. ResearchDx’s core consulting services — CLIA licensure, CAP/ISO 15189 accreditation, and validation support — are exactly the pathway your laboratory needs today.
Some organizations pursue FDA clearance or approval voluntarily — for competitive differentiation, to support reimbursement discussions, to enable broader commercial distribution beyond the single-lab LDT model (i.e., converting an LDT into a distributable IVD kit), or to commercialize a Companion Diagnostic. ResearchDx supports that path as well, including:
ResearchDx has extensive experience with the validation and clinical implementation of Next-Generation Sequencing technologies (NGS) in a CLIA-certified, CAP-accredited environment. We provide implementation services for novel NGS assays for qualified laboratories.
Whether you need full turnkey support or a targeted consultation on a single deficiency response, our team is ready to build the right scope for your organization.