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CMS regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total CLIA covers approximately 175,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

Background about CLIA

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. On February 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the FDA for home use, employ methodologies that are so simple and accurate that mistakes are unlikely and negligible; or pose no reasonable risk of harm to the patient if performed incorrectly.

Who regulates the CLIA Program?

CMS (Center for Medicare and Medicaid Services) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total CLIA covers approximately 175,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under CMS has the responsibility for implementing the CLIA Program.

Does my office or company need to apply for a certificate?

CLIA requires that all entities that perform even one test, including a waived test on ..."materials derived from the human body for the purpose of providing information for diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If any entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

How to Apply for a CLIA Certificate: Form CMS-116

CMS has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification, Form CMS-116. This form should be mailed to the address of the local State Agency for the State in which your laboratory resides. (The form is in an Adobe Acrobat file (form116.pdf) and requires the Adobe Acrobat reader software to view. The file contains the following-- Form CMS-116 (PDF 33K), Instructions for Completion, Guidelines for Counting Tests for CLIA and Tests Commonly Performed and Their Corresponding Laboratory Specialties/Subspecialties.

CLIA requires all entities that perform even one test, including waived test on ... "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.

NOTE: Your completed application should be forwarded to the address of the local State Agency for the State in which your laboratory resides. If you have any questions regarding the completion of the Form CMS-116, contact the appropriate State Agency as noted above. You should also contact this State agency for additional forms that may be necessary to complete the registration process or for any additional questions. For example, the State of California has additional licensure requirements and thus California applicants should be sure to contact their local State Agency --(213) 833-6000. Be sure to make contact with your State Agency to ensure that you have all the necessary information that is required for application.

How to Get With The CLIA Program

Call the Centers for Medicare & Medicaid Services number in your state (Table 1) and ask for a CLIA application form. It will take your account less than 10 minutes to fill out the form and mail it in. They will be billed $150 every two years and will probably have nothing more to do with the CLIA program.

Click here For Your State Information.

HOW TO GET A CLIA CERTIFICATE OF WAIVER

STEP 1: Call your state Centers for Medicare & Medicaid Services (CMS, formerly Health Care Financing Administration or HCFA) office and request Form # 116 and any other forms that may be required to get a CLIA certificate. For the CMS telephone number in your state, call 410-786-3531 or visit the CMS web site at www.hcfa.gov.

STEP 2: You will then complete CMS Form # 116 and check "Certificate of Waiver" in Section 2.

STEP 3: You can begin testing once Form # 116 has been returned to CMS. Once CMS receives their payment, your account will receive a CLIA identification number that must be included on all Medicare and Medicaid claims. CLIA certificates (including fees) are renewed every 2 years.

Who Needs A CLIA Certificate?

Any place that tests human specimens (this includes blood, urine, and assorted other body fluids) to diagnose, treat or monitor patients should get with the CLIA Program, even if you only perform so-called "simple" tests, such as urine dipsticks and microscopic tests. Regardless of whether an account bills Medicare for these tests, they are still required by law to sign up with CLIA.

…And Who Doesn't?

Medical practices that only draw blood to refer out (and do not perform urine dipsticks or other in-house testing) or only perform workplace drug testing, are exempt from CLIA.

When a CLIA certificate is needed and when it isn't.

When to Get A CLIA Certificate

Get A CLIA Certificate If You…. Perform tests from human body fluids that are used to diagnose, monitor or treat disease. Perform simple tests such as blood glucose meters or urine dipsticks.

Do Not Get A CLIA Certificate If You…. Perform tests only for research or other purposes (e.g., workplace drug screening). Perform physiological tests only (ECG, spirometry, pulse oximetry, etc.) Collect specimens and refer elsewhere for testing Just do autoclave spore checks

For waived tests, no daily quality control is required (unless the manufacturer specifically states this, and many don't), nor is proficiency testing needed. Finally, virtually no waived site will be inspected. The exception is in a handful of states, such as Pennsylvania, where some of the recently waived tests are not yet recognized as waived and are subject to daily QC and proficiency testing.

Fact vs. Fiction about CLIA-Waived Tests

Customer Objection
Waived-Test Response

CLIA is too much hassle.
The only requirement for waived tests is to "follow the manufacturer's instructions"

CLIA is too expensive.
You can recoup the $150 during the first week of testing! And CLIA fees are only collected every two years. You can save a lot of money by switching out your moderately-complex tests with waived ones, where possible. Why? Because you do not need to perform quality control and proficiency testing on waived tests. This can amount to savings of several hundred dollars per year.

I don't want to hire a tech.
Anyone who can fog a mirror can perform a waived test.

Once we run our daily quality control we'll lose money on the test.
Daily QC is not required for waived tests, unless specifically stated in the manufacturer's instructions (and it isn't)

I don't want the feds inspecting my office.
Labs that only perform waived tests are not inspected.

Excerpts from an article by Dr. Sheila Dunn