At a glance
Background
All facilities in the United States that perform laboratory testing on human specimens 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 are regulated under CLIA.
Waived tests are defined as simple procedures with a low risk for error, such as rapid strep tests or glucose monitoring, and are subject to minimal regulatory oversight. In contrast, nonwaived tests are more complex than those that are waived and are categorized as either moderate or high complexity.
As a result, these nonwaived tests are subject to the full scope of CLIA requirements across the total testing process,[1] including personnel qualifications, quality control, and ongoing oversight, regardless of whether they are categorized as moderate or high complexity.
Given these requirements, laboratories must remain vigilant, as errors can still occur due to various factors. Such errors may result from improperly trained personnel, inadequate quality control practices, failure to follow validated procedures, or breakdowns in specimen handling and result reporting. The consequences of these errors can be severe, including misdiagnosis, inappropriate treatment, or delayed care.
CLIA Certification
Get information about W-9 forms, certificate status, renewal fee coupon, updating certificate information, regulations, and licensure from your state agency.
Need help?
- Contact your State Agency or Accreditation Organization (for accredited laboratories).
- Refer to the FAQs about the Transition to Paperless, which provides key information to support your laboratory following the transition.
Visit the CLIA website for more information.
Educational Materials
Performance Specifications Essentials Booklet
This booklet outlines regulatory requirements for the establishment and verification of performance specifications for nonwaived tests under CLIA (42 CFR § 493.1253).
Contact Information
For questions or comments, please email the Division of Laboratory Systems at dlsinquiries@cdc.gov.
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