What is the purpose of the Clinical Laboratory Improvement Amendment?

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Last updated: June 30, 2018

The clinical laboratory improvement amendments (CLIA) are a set of codes in a federal mandate passed in 1988 that covers benchmark methods associated with collecting, analyzing, and interpreting human specimen results for medical examination purposes. CLIA was introduced to guarantee that all laboratories and healthcare facilities that contribute to CLIA funded programs comply with current policies and practices in maintaining quality patient care and confidentiality. The Department of Health and Human Services (DHHS) has direct authority in granting certification approval to laboratories and all related healthcare providers. DHHS devolves administrative roles to three federal agencies including the Center for Disease Control and Prevention (CDC), Center for Medicare and Medicaid Services (CMS), and Food and Drug Administration (FDA).

From the beginning, CLIA-based sponsors including clinics, laboratories, hospitals, outpatient offices, and private practice doctors have contributed to the upside of delivering accurate, effective, and reliable testing policies and procedures. Individuals and/or organizations affiliated with CLIA-based programs are required to complete an application, submit fees, pass survey requirements, and maintain CLIA code of standards.

CLIA certification generally reflects testing methods performed by different institutions based on variable factors including moderate/high laboratory complexity procedures, annual patient visits, and the nature of testing. Depending on testing requirements, laboratories garner their credentials following mandatory field surveys by a CMS agency representative who evaluates current medical testing standards are upheld. Laboratories and relevant healthcare organizations can apply for a number of certificate privileges covering an assortment of testing measures. There are five subclasses of certificates recognized by CLIA including Certificate of Waiver (CW), Certificate for Provider-Performed Microscopy Procedures (PPMP), Certificate of Registration (COR), Certificate of Compliance (COC), and Certificate of Accreditation (COA).

In addition, laboratory facilities that conduct moderate to high complexity methodologies must adhere to proficiency testing (PT) regulations to ensure pivotal aspects of medicine are observed. These include employing current technical applications and/or equipment, delivery of optimal patient care, and releasing laboratory test results to patients and/or designee per CLIA rules aligned with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

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The Centers for Medicare & Medicaid Services (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 330,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) 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.

For the following information, refer to the downloads/links listed below:

Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency;
Frequently asked Questions (FAQs), Abbott i-STAT;
For additional information about a particular laboratory, contact the appropriate State Agency (PDF) or CLIA
Operations Branch;
Information about what is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority is found in the downloads section in the file called "LDT and CLIA FAQs";
CMS Blog - FDA & CMS Form Task Force on LDT Quality Requirements;
Information on research testing and CLIA is found in the file called "Research Testing and CLIA";
Information about direct access testing (DAT) and the CLIA regulations is included in the Direct Access Testing download;
OIG reports relating to CLIA;
Guidance for Coordination of CLIA Activities Among CMS Central Office, CMS Regional Offices, State Agencies (including State with Licensure Requirements), Accreditation Organizations and States with CMS Approved State Laboratory Programs is contained in the Partners in Laboratory Oversight download;
Micro sample pipetting information for laboratories;
Information on alternative (non-traditional) laboratory is contained in the Special Alert download;
FDA Safety Tip for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices; and
CDC educational booklet, "PROVIDER-PERFORMED MICROSCOPY PROCEDURES - A Focus on Quality Practices" (In the Related Links section.); and
Frequently asked questions to S&C-16-18-CLIA, Personnel Policies for Individuals Directing or Performing Non-waived Tests, are in the Downloads section file called "S&C-16-18-CLIA FAQs".

COMPLAINT REPORTING

To report a complaint about a laboratory, contact the appropriate State Agency (PDF) that is found on the State Agency & Regional Office CLIA Contacts page located in the left-hand navigation pane in this section. See the Consumer Complaints FAQ (PDF) on how to file a complaint. Additionally, see the Temporary COVID-19 Testing Sites (PDF) infographic, which advises those receiving laboratory services of things to be aware of to ensure they are receiving quality laboratory testing.

QUESTIONS ABOUT the CLIA PROGRAM

For Questions regarding a CLIA certificate or fees: If you have a question related to CLIA fees or payment, CMS-116 applications, demographic updates, certificate status or upgrades, and/or Laboratory Director changes, please call your local State agency for assistance. Select the State agency based on the physical location of the laboratory. The State agency maintains the certificate information for new and existing laboratory providers within their state. For a list of our State agency CLIA contacts (PDF), please visit our website at /Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf (PDF)
All other questions about the CLIA program should be submitted to .

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The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.[1]

In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing.[2] CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for:[citation needed]

diagnosis, prevention, or treatment of disease or impairment
health assessments

An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program.[3] In 2014 the FDA started a public discussion about regulating some LDTs.[4]

Per CLIA, each specific laboratory system, assay, examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the following seven criteria. A score 1 is the lowest level of complexity and a score of 3 indicates the highest level. Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.[5]

Criteria for categorization:

Knowledge
Training and experience
Reagents and materials preparation
Characteristics of operational steps
Calibration, quality control, and proficiency testing materials
Test system troubleshooting and equipment maintenance
Interpretation and judgment

Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.

The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.[3]

Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.[6] In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver,[7] although many waived tests are not done according to designed protocols – more than 50% of such tests are done incorrectly – and result in medical errors, some with fatal consequences.[8]

CLIA[9] and the College of American Pathologists (CAP)[10] have written policies for the minimum period of that laboratories should keep laboratory records and materials, with some examples as follows:

Microscopy slides	Histology and non-forensic autopsy	10 years[9]
Forensic autopsy	Indefinitely[9]
Cytology, fine needle aspiration	10 years[10]
Cytology, apart from fine needle aspiration	5 years[9]
Paraffin-embedded blocks	Non-forensic	2[9] or 10 years[10]
Forensic	Indefinitely[9]
Requisition form and test report	Pathology reports	10 years[9]
Other	2 years[9]
Blood bank records	Quality control records	5 years[10]
Donor and recipient records	10 years[10]
Records of indefinitely deferred donors	Indefinitely[10]
Wet tissues	Until report is completed[9] or 2 weeks thereafter[10]
Proficiency testing records and quality management/quality control records	2 years[9]
Discontinued procedures	2 years[9]
Blood smears and other body fluid smears, microbiology slides (including Gram stains)	7 days[10]
Flow cytometry plots	10 years[10]

Medical technologist

^ CLIA related Federal Register and Code of Federal Regulation Announcements, and the FDA's Clinical Laboratory Improvement Amendments (CLIA). Accessed Nov. 14, 2015.
^ CLIA Program homepage
^ a b "CLIA Overview". CMS. 11 April 2018.
^ "Laboratory Developed Tests". FDA. 26 March 2018.
^ CLIA Categorization Criteria (December 2012)
^ "CLIA Waived Testing booklet" (PDF). December 2012.
^ "CLIA Waived IVD Regulatory Assistance". November 2007. Archived from the original on 2012-12-05. Retrieved 2012-12-10.
^ Gabler, Ellen (2015-10-31). "Hidden Errors – A Watchdog Report – Common medical tests escape scrutiny but often fall short". Milwaukee Journal Sentinel. Retrieved 2017-10-10.
^ a b c d e f g h i j k "42 CFR § 493.1105 - Standard: Retention requirements". Cornell Law School. [68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]
^ a b c d e f g h i "CAP Policy Manual - Policy PP. Minimum Period of Retention of Laboratory Records and Materials" (PDF). CAP.org. Adopted August 1995. Revised September 2020