What is CLIA registration and what is its purpose?

What is the meaning of CLIA?

The clinical laboratory improvement amendments of 1988 is a federal program governed by CMS- Centers for Medicare and Medicaid Services. Its main purpose is to create and establish quality standards for clinical laboratory testing to make sure that the test results of all the patients are reliable, timely and accurate. The goal of CLIA is to monitor the patient test results in the hospitals, laboratories, medical physicians and practitioners, and clinics of the particular state in which they are located. 

In the ordinary sense, a CLIA certification has to be obtained by the organizations that are going to perform laboratory testing on the human specimens such as blood, body fluid, and tissue, for the major reasons related to diagnosis, prevention as well as treatment of a particular disease. A CLIA certificate is required before performing such tests so that quality standards could be established. 

Who needs to obtain a CLIA certificate?

Any organization authorized to perform laboratory tests on human specimens for the treatment or diagnosis purpose is mandated to obtain a CLIA certificate by federal law. An organization must obtain and maintain a CLIA certificate if it is going to perform such tests which are considered to be laboratory tests according to the federal law. It is immaterial whether such laboratory tests will be reimbursed or not. A CLIA certificate will have to be obtained. 

Are there some kinds of tests that do not require any certification?

Yes, there are a few exceptions that do not require the certification. Below are mentioned some of the tests for which a CLIA certification is NOT required:

• Blood draws

• Specimen collections

• Any laboratory that is conducting only Forensic testing

• Drug testing for employment purpose

• Laboratories that are certified by SAMHSA, in which drug testing is performed as per the guidelines issued by SAMHSA. However, a CLIA certificate is required in all the other tests as conducted by a SAMHSA (Substance abuse and mental health services administration) certified laboratory. 

In short, if you are not going to perform any on-site testing, you need not obtain a CLIA certificate in such cases. The main purpose of the test will determine whether it requires a CLIA certification or not.

Do I need to obtain a CLIA certificate?

Generally, CLIA mandates that all the facilities performing even one of the applicable tests on any “type of materials derived from the human body such as blood, body tissue, etc. for diagnosis, prevention or treatment of any disease, or for the assessment of health”, need to conform to certain federal requirements. 

If a facility/organization performs any such applicable test, it will be considered as a laboratory test as per CLIA and the facility will generally have to obtain a CLIA certificate that corresponds to the complexity of these tests. In addition to this, there is a point to be noted that you will not require to obtain a CLIA certificate if you are located in any of the states of Washington or New York, as these states have their own operated laboratory regulatory programs. You are required to contact the appropriate agency in the state to determine whether you require a CLIA certification or not. 

Types of CLIA certificates

Generally, all types of certificates are valid for two years. Some of the CLIA certificates are – certificate of waiver, certificate of registration, certificate of compliance, certificate of accreditation.

Additionally, there are 7 CMS-approved accreditation organizations which are listed below-

• AABB

• College of American Pathologists

• American Society for Histocompatibility and Immunogenetics

• The joint commission

• COLA

• American association for laboratory accreditation

How should I apply for a CLIA certificate?

The CLIA application form is very easily available online (Form CMS-116). Complete your application and send it to your local state agency in which the laboratory is situated. In addition to this, check for any other specific requirements that might be demanded by your state agencies. If you are not able to find your state agency online then you may contact their helpline number and get the details of your state agency. In case, you are looking forward to any kind of details related to CLIA certification, you should contact your state agency and get the information on priority.