CLIA for physician office laboratories
Following CLIA standards can help ensure quality and accurate lab testing in your practice.
What is CLIA?
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are federal regulations that apply to all U.S. facilities and CLIA-certified international laboratories that test human specimens to assess health or diagnose, prevent or treat disease. The CDC supports the CLIA program in partnership with the CMS and FDA.
These regulations help ensure testing meets quality standards so patients and physicians are confident test results are accurate and reliable.
CLIA certification and licensing
You need a CLIA certificate before you test human samples. The kind of certificate you need is tied to how complex your tests are and what you run. If your facility performs even one test on a human specimen to assess health or to diagnose, prevent or treat disease, CLIA treats you as a lab and requires certification.
CLIA certificate types
Certificate of Waiver (CoW): Permits only CLIA-waived tests performed per manufacturer instructions. It is not subject to routine biennial inspections and is valid for two years.
Certificate for Provider-Performed Microscopy Procedures (PPMP): Allows a defined set of moderate-complexity microscopy during patient visits by physicians, nurse practitioners, nurse midwives, physician assistants or dentists, and permits waived tests. Holders aren’t subject to routine biennial inspections. Complaint and educational visits may still occur. (CDC: PPMP Quality)
Certificate of Compliance (CoC): Authorizes moderate- and high-complexity testing and is inspected by CMS or its state agency surveyors for federal CLIA compliance. Routine surveys occur about every two years, with complaint or validation surveys possible at any time.
Certificate of Accreditation (CoA): Authorizes moderate and high complexity testing through a CMS-approved accrediting organization (e.g., CAP, COLA, The Joint Commission). Accreditor surveys follow CLIA-equivalent standards on an approximately biennial cycle. CMS may also perform validation or complaint surveys.
Get certified: Forms and guides
CLIA certified vs. CLIA waived labs
CLIA-certified is a general term for any site holding a CLIA certificate (CoW, PPMP, CoC, or CoA). A CLIA-waived lab holds a CoW and may perform only waived tests following manufacturer instructions.
How to obtain a CLIA certificate
Define your test menu and complexity. Check whether each test is waived or non-waived (moderate/high) using FDA’s CLIA database.
Complete CMS Form-116 and contact your state CLIA agency for where to submit and fee details.
Select the right certificate type (CoW, PPMP, CoC, or CoA), pay fees, and begin testing after you receive the certificate.
CLIA regulations and compliance standards
Compliance standards for non-waived testing
If you perform any moderate- or high-complexity testing, including PPMP procedures, you must follow CLIA’s quality system (subpart K) and personnel standards (subpart M) tied to non-waived testing.
Key CLIA standards (primary sources)
Quality system (subpart K): Outlines requirements, including maintaining a written procedure manual, managing pre-analytic/analytic/post-analytic steps, running quality control and proficiency testing and documenting corrective actions. (CDC: About laboratory quality)
Procedure manual requirements (493.1251): Details what your manual must include and how to maintain it.
Performance specifications (493.1253): Explainshow to establish and verify accuracy, precision, reportable range and reference intervals. (CMS: Verification of Performance Specifications)
Personnel standards (subpart M): Outlines requirements for providing qualified leadership and defined roles with documented training and competency for all testing personnel. (CMS: Assessing personnel competency)
Survey procedures and guidelines: Explains how labs are surveyed and interpreted. (operations manual PDF (Rev. 02-03-17)
Thinking about full accreditation?
State laboratory licensing
While CLIA certification is federal, many states also require a separate state laboratory license or registration, even for waived testing. In the two CLIA-exempt states (Washington and New York), the state program substitutes for federal CLIA. However, New York’s exemption is partial, so some physician-office labs use the Physician Office Laboratory Evaluation Program (POLEP) track while others fall under the Clinical Laboratory Evaluation Program (CLEP).
Examples of state variations
Registration vs. licensing for waived or PPMP sites
(California registers waived/PPMP and licenses moderate/high).Who inspects and how often
(state surveyors or a state-run program in CLIA-exempt states such as Washington).Personnel licensure and qualification rules beyond CLIA
(some states license individual lab personnel).
Operating in CLIA-exempt states
One medical test site license covers state and CLIA. There is no separate CMS application.
Most clinical labs use CLEP, but you can use POLEP if you meet the state’s physician-office lab exception and test only your patients. POLEP follows federal CLIA and accepts the CMS-116.
How to confirm your state’s rules
Start with CMS state agency contacts for your location. They can clarify whether you need a state license, a registration or both.
CLIA waived tests in family medicine
What is a CLIA waived test?
Waived tests are simple, low-risk exams either cleared by FDA for home use or specifically approved for waiver under CLIA criteria. CLIA-waived tests are the simplest category of clinical testing. They use straightforward steps and easy-to-read results, so little interpretation is needed. When they’re performed exactly as the manufacturer instructs, they may be run in physician offices and other near-patient settings under a CoW. Waived doesn’t mean hands-off. Basic training, good lab practices and documentation still apply.
There are CDC tools to help you set up and monitor your waived program. The agency’s To test or not to test? guidance explains when and how to implement CLIA-waived testing and includes ready-to-use forms and reminders. The companion self-assessment checklist offers a voluntary way for physicians, nurses and other staff to confirm good testing practices and reliable results over time.
Examples of CLIA waived tests
Common categories of waived tests in family medicine are listed below. Waiver applies to specific test systems, not just test types, so status can vary by brand and model. Before you add a method to your menu, confirm the exact kit’s waived status in the FDA database of currently waived analytes.
Common examples of waived tests
Capillary blood glucose meters
Urine pregnancy (hCG) tests
Dipstick urinalysis
Fecal occult blood tests
Certain rapid antigen tests (e.g., group A strep, influenza)
CLIA waiver application process
If you plan to perform only waived tests, apply for a CoW (CMS-116), pay the fee, renew every two years and follow manufacturer instructions and good lab practices. The CMS PDF How to obtain a CLIA certificate offers step-by-step guidance.
CLIA lab operations and search tools
CLIA laboratory setup for family practices
Set up your office lab so testing is safe, traceable and survey ready. The points below provide the basics of what you need for waived testing along with the added structure you need for non-waived work.
Space and safety
Designate a clean testing area, post safety signage, manage sharps and waste per OSHA, keep PPE stocked. (29 CFR 1910.1030) (42 CFR 493 subpart J)Test menu governance
List exactly which methods you run, confirm each kit’s waived or non-waived status and review the menu at least yearly. (FDA: CLIA database)Procedure manual
Keep current, bench-available procedures for each test, including collection, labeling and transport, quality control and corrective steps. (42 CFR 493 subpart K 1251)Supplies and equipment
Track lot numbers and expiration dates, maintain temperature logs for refrigerators and rooms, schedule instrument maintenance. (42 CFR 493 subpart K 1200)Training and competency
Train all staff before testing and document competency on hire and at required intervals; include direct observation and record review. (42 CFR 493 subpart M 1351)Quality checks
Follow manufacturer quality controls for waived tests. For non-waived testing, add proficiency testing, method verification and ongoing quality indicators. (42 CFR 493 subpart H 801 and subpart K 1200)Order-to-result workflow
Standardize patient ID, specimen handling and result entry and review, with a plan for reflex or send-out testing when needed.Result communication and follow-up
Define who reviews abnormal results, how you notify patients and how you close the loop on repeats or referrals.Downtime and backup
Keep a backup communication plan, an alternate analyzer or send-out option and a paper process for orders and results during outages.Readiness and documentation
Display your CLIA certificate, keep survey-ready records, track issues with an incident log and corrective actions, and follow (42 CFR 493 subpart J 1105) record retention requirements.
CLIA laboratory search and verification
Need to verify a referral lab’s certificate or look up your record? Use the CMS quality certification and oversight reports (QCOR) CLIA laboratory lookup. The CDC retired its search tool in 2024 and points users to QCOR.