Below you will find country-specific information on licensing regulations for all mandatory laboratory positions as well as all forms and applications related to the start-up and operation of your clinical laboratory. Although CLIA is a federal program, state agencies (SA) are responsible for overseeing laboratory oversight and maintaining CLIA laboratory certification records. SAs (PDFs) process CLIA (PDF) applications, renewals, updates and requests for copies of certificates. Some states also have lab licensing laws that are separate from CLIA regulations, so please check with your SA before your lab starts testing. Conditions for which a clinical isolate or clinical sample must be submitted to the Public Health Laboratory (2016). The Centers for Medicare & Medicaid Services (CMS) governs all laboratory tests (except research) performed on people in the United States through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA includes approximately 330,000 laboratories. The Clinical Laboratory Improvement and Quality Division within the Quality, Safety and Surveillance Group of the Centre for Clinical Standards and Quality (CCSQ) is responsible for the implementation of the CLIA program. To report a complaint about a laboratory, contact the appropriate state agency (PDF), which can be found on the CLIA contact page of the State Agency and WHO/Europe in the left navigation pane of this section. For more information on submitting a complaint, see the Consumer Complaints FAQ (PDF).
For more information, see the temporary COVID-19 testing sites infographic (PDF), which informs those receiving lab services about the things they need to keep in mind to ensure they receive high-quality lab tests. CMS Investigation Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Appendix C)External Symbol The design guidelines for CLIA regulations are published in the CMS State Operations Manual (SOM). Som is used by state agencies to administer various federal programs, such as the certification of clinical laboratories in accordance with CLIA regulations, and is enforced by CMS. It is also a source of guidance for laboratories for the interpretation of CLIA regulations. Our state license card resource is designed to help our clinical laboratory customers and medical laboratory scientists find all the information they need to obtain the required government personnel and facility licenses. The goal of the CLIA program is to ensure high-quality laboratory testing. Although all clinical laboratories must be duly certified to receive Medicare or Medicaid payments, CLIA has no direct responsibility for the Medicare or Medicaid program. The Clinical Laboratory Improvement Act of 1988 is an amendment to the Public Health Services Act in which Congress revised the federal program for the certification and oversight of clinical laboratory tests. Two other changes were made after 1988. The law continues to be cited as CLIA `88, as it is called in the legislation.
The operation of California`s clinical and public health laboratories is subject to various regulatory laws. Here are the applicable regulations. The following pages on government regulations refer to this page. The section of federal regulation titled “Standards and Certification: Laboratory Requirements” is published by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA Act passed by Congress (see below). In general, CLIA regulations set quality standards for laboratory tests performed on samples from people such as blood, body fluids and tissues for the purpose of diagnosing, preventing or treating a disease or assessing health. The final rules of the CLIA were published in 1992, phased in 1994 and amended in 1993, 1995 and 2003. Visit the CLIA Documents page to view Federal Register notices and previous editions of the Code of Federal Regulations (published annually in October). 1 See 1997 Changes to the CLIA `88pdf icon 2 See 2012 Changes to the CLIA `88pdf icon Sign up for our CLIA Communications mailing list with the following link: public.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12461. Current through Register 2022 Notice Reg. No. 16, April 25, 2022 Clinical Laboratory Improvement Amendments (42 USC 263a)pdf iconExternal mark Source: Government Printing Office (GPO) Federal Digital SystemOutdoor page. AB186 Guidance for Reporting Select Agent test requests and results (2014) Note: The cited authority: Sections 208(a) and 1275, Health and Safety Code.
Reference: Article 1276, Health and Safety Code. The following information can be found in the downloads/links listed below: Title 17 CCR Section 2505. List of Laboratory Notifiable Diseases (2016). Note that different jurisdictions may have additional reporting requirements. Check the requirements of your local health authority.