6: CLIA

Last updated

Mar 13, 2025
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- 5: Health Careers
- Back Matter

Kari Christenson, Western Technical College

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Learning Objectives

Course Competency: Evaluate laboratory compliance with CLIA regulations.

Learning Objectives:

Describe the major components of CLIA
Explain the relationship of one CLIA component to another
Demonstrate understanding of regulatory compliance
Explain the proficiency testing process

Clinical Laboratory Improvement Amendments (CLIA)¹

All clinical laboratories that perform tests on human specimens are regulated by both federal and state agencies. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988, setting quality standards for all lab testing. CLIA ensures the accuracy, reliability, and timeliness of patient test results, regardless of where the test is performed. The CLIA regulations are based on the complexity of the test method. That means the more complicated the test, the more stringent the requirements. The type of CLIA certificate a lab must have depends on the type of testing the lab performs.

Under CLIA, a clinical laboratory is defined as a facility that performs testing 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 health of human beings. These exams also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. If a facility performs tests for these purposes, regardless of whether there is reimbursement for such tests, it is considered a laboratory according to the definition by CLIA. Therefore, it must obtain and maintain CLIA certification. Facilities only collecting or preparing specimens (or both) - or only serving as a mailing service and not performing testing on patient specimens - are not considered clinical laboratories.

Although CLIA is a federal program administered by CMS (Centers for Medicare & Medicaid Services), state agencies are responsible for overseeing labs and maintaining CLIA labs' certification records. State agencies process CLIA applications, renewals, updates, and requests for certificate copies. In addition, state agencies inspect and monitor clinical labs for compliance of federal CLIA regulations. They also investigate complaints to ensure testing is accurate, effective, and reliable.

CLIA Categorizations²

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. Classifications are based on the difficulty of the test procedures and the level of training required to accurately perform the tests. Standards for laboratory personnel differ for each category. The more complex the test, the more highly trained the testing personnel must be. The CLIA Program grants 5 types of lab certificates and each laboratory must obtain a certificate stating its classification.

Waived Tests

Diagnostic tests are categorized as waived based on the premise that they are simple to use, and there is little chance the test will provide wrong information or cause harm if it is done incorrectly. Tests that are cleared by the FDA for home or over-the-counter use are automatically assigned a waived categorization.

For a complete list, refer to the CDC's Waived Test List.

Nonwaived Tests

Moderate and high complexity tests are also called nonwaived tests. The FDA determines the test’s complexity by reviewing the package insert test instructions and using a criteria “scorecard” to categorize a test as moderate or high complexity. Each test is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria on the scorecard.

CLIA Categorization Criteria³

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

A score of 1 indicates the lowest level of complexity, and the score of 3 indicates the highest level. The 7 scores are added together and the tests with a score of 12 or less are categorized as moderate complexity, and those with a score above 12 are categorized as high complexity.

Additional information is available at the FDA's CLIA Categorizations webpage.

Survey Process⁴

Labs are surveyed or inspected to ensure that CLIA regulations are met.Surveys may be scheduled in advanced or unannounced. The survey process is outcome-oriented, the intent of which is to focus the surveyor on the overall performance of the laboratory and the way it monitors itself, rather than on a methodical evaluation of each requirement. During the information gathering portion, surveyors review a variety of records including the lab's operating procedures, quality assurance records, proficiency testing reports, personnel records, and patient test results. They also conduct observations and interviews.

The surveyor analyzes all collected information to determine whether the laboratory has complied with applicable federal regulations. The surveyor reviews these findings in an exit conference and summarizes the survey findings in a written final report. Any deficiencies are discussed and addressed between the surveyor and the lab.

For additional information about the Wisconsin survey process, refer to the WI Department of Health Services (DHS) Survey Guide: Clinical Laboratories, P-01227.

Proficiency Testing⁵

CLIA regulations require a laboratory to have quality control procedures to ensure accuracy and reliability of test results. Proficiency testing, or PT, is the process used to evaluate a laboratory’s performance and maintain quality control among laboratories.

Enrollment in an external proficiency testing program is required for laboratories performing moderate or high complexity tests. Only waived tests are exempt from proficiency testing regulations. If a laboratory performs only waived tests, it is not required to participate in a proficiency testing program. However, it must apply for and be given a certificate of waiver.

PT is a useful tool to:

Verify testing accuracy and reliability
Validate the entire testing process, including the testing personnel competency.

PT reports can alert laboratory staff and the laboratory director to testing phases (for example, pre- or post-analytical) that aren’t performing as expected. Routinely reviewing PT reports can also indicate subtle shifts and trends that, over time, could affect patient results.

PT Process

Proficiency testing programs are available through the College of American Pathologists, the Centers for Disease Control and Prevention, and the health departments in some states (ex. Wisconsin State Lab of Hygiene). An HHS-approved external PT program sends 5 samples to the laboratory on a regular basis (usually 3 times each year) for testing. Each shipment of PT samples is called an "event."

Labs must test PT samples the same way they test patient specimens. This means:

Testing the PT samples the same number of times as labs would test patient specimens.
Testing at the same time as patient specimens.
Testing by the same personnel that routinely test the patient specimens.
Using the same test system, including analyzer and reagents, that you routinely use for the patient specimens. PT samples should also be rotated among the laboratory’s testing personnel.

Laboratories must not communicate with other labs regarding PT values and the lab must not send the PT samples to another lab.

The laboratory must also document its process for all PT samples and this information must be kept for two years. When testing is complete, the laboratory reports its results to the PT program, which then grades the results against CLIA performance criteria and sends the laboratory a score. All PT results must then be reviewed, signed, and dated by the lab. CMS and accreditation organizations routinely monitor each laboratory’s score and overall performance.

Performance Criteria and PT Failure

CMS specifies acceptable performance criteria for each analyte. An 80% or better is acceptable (0 or 1 wrong out of the 5 samples), but failing even a single analyte requires the lab to investigate and correct the problem as well as document their actions. More than 1 incorrect result is a failure for that analyte in that event. CMS labels this "unsatisfactory" and requires corrective action.

If multiple PT events are failed, CMS labels this as "unsuccessful" and the lab would need to create a plan for correction of the problem and undergo ongoing monitoring. Repeated unsuccessful performance may result in the laboratory no longer being allowed to perform the failed testing. In addition, CMS may revoke the lab's certificate and stop Medicare/Medicaid payments.

Commons causes of PT failure include missing or inadequate samples, test procedural errors, improperly calibrated instruments, incomplete forms, transcription errors, and failure to return samples by the deadline. All failures must be investigated to determine the type of error and correct the problem. Labs must also document all corrective action taken.

References

¹This section is minimally adapted from Clinical Laboratory Improvement Amendments (CLIA), Wisconsin Department of Health Services (DHS). Retrieved January 28, 2025. Used with permission from the State of Wisconsin.

²Adapted from 8.3 Regulation of Clinical Tests, Jack O'Grady, Austin Community College. CC BY.

³ CLIA Categorizations, U.S. Food and Drug Administration. Public Domain. Retrieved January 28, 2025.

⁴This section is adapted from the Survey Guide for Clinical Laboratories, Wisconsin Department of Health Services (DHS). Retrieved January 28, 2025. Used with permission from the State of Wisconsin.

⁵ Proficiency Testing and PT Referral (2024, June), Centers for Medicare & Medicaid Services. Public Domain.

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Learning Objectives

Clinical Laboratory Improvement Amendments (CLIA)1

CLIA Categorizations2

Survey Process4

Proficiency Testing5

References

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Clinical Laboratory Improvement Amendments (CLIA)¹

CLIA Categorizations²

Survey Process⁴

Proficiency Testing⁵