What is CLIA?
Clinical Laboratory Improvement Amendments (CLIA): Diagnostic testing helps healthcare providers diagnose or monitor specific diseases or conditions. It helps assess patient health and make clinical decisions about patient care. In short, CLIA program is to ensure quality laboratory testing.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA – Each agency has a unique role in assuring quality laboratory testing.
- The Food and Drug Administration (FDA),
- Center for Medicaid Services (CMS), and
- Centers for Disease Control and Prevention (CDC).
FDA
- Categorizes tests based on complexity
- Reviews requests for Waiver by Application
- Develops rules/guidance for CLIA complexity categorization
CMS
- Issues laboratory certificates
- Collects user fees
- Conducts inspections and enforces regulatory compliance
- Approves private accreditation organizations for performing inspections, and approves state exemptions
- Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
- Publishes CLIA rules and regulations
CDC
- Provides analysis, research, and technical assistance
- Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
- Conducts laboratory quality improvement studies
- Monitors proficiency testing practices
- Develops and distributes professional information and educational resources
- Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)
Clinical Laboratory Improvement Amendments (CLIA)
CLIA is a federal program, State Agencies (SAs) are responsible for laboratory oversight and maintaining CLIA laboratories’ certification records. SAs (PDF) process CLIA applications (PDF), renewals, updates, and requests for certificate copies. Some states also have laboratory licensing laws separate from the CLIA regulations, so please check with your SA before your laboratory begins testing.
CLIA Number
Upon certification, a ten-digit alphanumeric character gets assigned to the laboratory site. CLIA number filled in block 23 of Form CMS-1500 manually or documented electronically.
How to Apply for a CLIA Certificate, Including International Lab?
The CLIA requirements are based on the complexity of the test and the type of laboratory where the testing is performed.
Applying for a CLIA Certificate
What Form Do I Use to Apply?
Complete the Application for Certification Form (CMS-116), unless you’re:
- A New York state non-physician office laboratory applicant. Email or call the New York State Department of Health at (518) 485-5378 for guidance.
- A Washington state applicant. Email or call the Washington State Agency at 253-395-6746 for guidance.
- Applying from outside the U.S. and its territories. Email the International Laboratory CLIA Certification Process before completing the CMS-116 form.
Where Do I Send My Completed CLIA Form?
Submit the CMS-116 form and other required documents to your State Agency, which will process your application.
What Credentials Do I Need to Apply?
Directors Who Perform Non-Waived Testing
Laboratory directors who perform non-waived testing (including Provider Performed Microscopy (PPM)) must meet specific CLIA education, training, and experience requirements. As mentioned in the CMS-116 form instructions, proof that the laboratory director has met these requirements must be submitted with the CMS-116 form, as noted in the instructions.
Applicants Who Attended Foreign Schools
Applicants who attended foreign schools must have their credentials evaluated to be sure their education is equivalent to education obtained in the U.S. Failure to submit this information will delay your application’s processing.
What credentials are needed to be a laboratory director for a CLIA certificate of waiver (CoW)?
A laboratory with a CLIA CoW must have a laboratory director, but there are no federal CLIA educational nor experiential qualifications for the laboratory director.
Which Facilities Need to Apply?
Under CLIA, a facility is a laboratory if it performs even one 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.” This includes tests categorized as waived complexity tests. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service aren’t considered laboratories.
A CLIA certificate isn’t required for:
- Forensic testing
- Blood draws
- Specimen collections
- Drug testing for purposes of employment; unless employment drug testing is done and individual treatment is offered or made available, then a CLIA certificate is required
What is the purpose of CLIA?
The Clinical Laboratory Improvement Amendments (CLIA) Program regulates labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done.
What are the 3 CLIA categories?
The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.
What are 4 examples of CLIA waived tests?
As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”
Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.
CMS maintains a complete list of waived tests for CLIA.
Which CPT codes are CLIA waived?
LAB TESTS REQUIRING MODIFIER QW: Certain codes describe only CLIA-waived tests and therefore are exempt from the requirement to add the QW modifier. The CPT codes for the tests currently exempt from the requirement are 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651.
What are CLIA samples?
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
What is the final rule of CLIA?
The final rule requires that the PT program have at least 10 laboratory participants for each specialty, subspecialty, and analyte or test for which the proficiency testing program is seeking reapproval.
CLIA Certification: 3 Things You Need to Know
CLIA regulatory requirements classify testing into three categories: high complexity, moderate complexity and waived.
CLIA License and Testing
The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress in 1988 establishing quality standards for all laboratory testing .
Who Needs a CLIA Certificate?
Any facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment.
Will I receive an identifying CLIA number?
You will receive a ten-character alpha-numeric code on the CLIA certificate. This number will be utilized to identify and track your laboratory throughout its entire history. You should use this number when making inquiries to the State Agency and CMS about your laboratory.
What are the different types of CLIA certificates and how long are they effective?
All types of certificates are generally effective for two years, and the different types of
certificates are:
- Certificate of Waiver (COW): Issued to a laboratory that performs only waived tests.
- Certificate for Provider-performed Microscopy (PPM) procedures: Issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient’s visit. A limited list of provider-performed
microscopy procedures is included under this certificate type, which are categorized as moderate complexity testing.
- Certificate of Registration* : Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories
applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration.
- Certificate of Compliance (COC): Issued to a laboratory once the State Agency or CMS surveyors conduct a survey (inspection) and determine that the laboratory is compliant with the applicable CLIA requirements. This type of certificate is issued to a
laboratory that performs nonwaived (moderate and/or high complexity) testing.
- Certificate of Accreditation (COA): Issued to a laboratory on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
A registration certificate is valid until an inspection is conducted and compliance is determined. As of the date of this publication’s release, there are seven CMS-approved accreditation organizations- AABB
- American Association for Laboratory Accreditation (A2LA)
- Accreditation Association for Hospitals and Health Systems/ Healthcare Facilities Accreditation Program (AAHHS/HFAP)
- American Society for Histocompatibility and Immunogenetics (ASHI)
- COLA
- College of American Pathologists (CAP)
- The Joint Commission
Download the PPT Presentation Resource for How to Obtain CLIA Certification?
