The Clinical Laboratory Improvement Amendments (CLIA) are a set of United States federal regulatory standards that apply to all clinical laboratory testing performed on humans, with the exception of clinical trials and basic research. Enacted in 1988, CLIA established a comprehensive quality framework for laboratory testing to ensure the accuracy, reliability, and timeliness of test results regardless of where the test is performed.
The importance of CLIA in the healthcare industry cannot be overstated. Laboratory testing influences nearly 70% of medical decisions, from diagnosis to treatment plans. Consequently, ensuring the quality and standardization of lab procedures is vital for patient safety and effective medical care.
History and Purpose of CLIA
Before CLIA was enacted, laboratory quality standards in the U.S. were minimal and inconsistently enforced. In the 1960s and 70s, several high-profile cases of laboratory errors that led to misdiagnoses and mistreatments began to raise public concerns. Despite some regulatory efforts, it wasn’t until the 1980s that national attention turned serious.
A pivotal moment occurred in the 1980s with the revelation that some laboratories were producing Pap smear results with significant error rates, which led to failures in early detection of cervical cancer. In response, the U.S. Congress passed CLIA in 1988 (Public Law 100-578) to implement standardized laboratory oversight and reduce such diagnostic errors.
CLIA was established with three key goals:
- Ensure the accuracy, reliability, and timeliness of test results
- Protect public health by reducing the risk of diagnostic errors
- Standardize lab testing procedures across all states and testing sites
What Does CLIA Cover?
CLIA regulations apply to all facilities that perform laboratory testing on human specimens for health assessment, diagnosis, prevention, or treatment. It is not limited to hospitals or large laboratories—even physician offices, urgent care centers, and mobile clinics performing point-of-care tests must adhere to CLIA rules.
CLIA oversight covers:
- Pre-analytical phase (e.g., specimen collection and handling)
- Analytical phase (e.g., actual testing procedures)
- Post-analytical phase (e.g., result interpretation and reporting)
It does not regulate medical practice or establish guidelines for the use of tests in clinical decision-making—CLIA’s focus is strictly on lab performance and quality assurance.
Types of CLIA Certificates
CLIA certification is issued by the Centers for Medicare & Medicaid Services (CMS). Laboratories are issued different types of CLIA certificates depending on the complexity of tests they perform.
Certificate of Waiver
- Description: For labs performing only waived tests, which are simple tests with a low risk of erroneous results.
- Examples: Urine pregnancy tests, blood glucose monitoring, some rapid COVID-19 tests.
- Oversight: Minimal; labs are expected to follow manufacturer instructions, but routine inspections are not required.
Certificate for Provider-Performed Microscopy Procedures (PPMP)
- Description: For physicians, midlevel practitioners, and dentists who perform simple microscopy procedures during patient visits.
- Examples: Wet mounts, urine sediment exams, and KOH preparations.
- Oversight: Requires a CLIA certificate and is subject to some oversight, including occasional inspections.
Certificate of Registration
- Description: Issued to new labs as an interim measure while the lab awaits a survey or inspection.
- Duration: Temporary and transitions into another certificate type once inspection is passed.
Certificate of Compliance
- Description: For labs that conduct moderate or high-complexity tests and are inspected directly by CMS or its designees.
- Inspection: Every 2 years or sooner if there are complaints or compliance concerns.
Certificate of Accreditation
- Description: Issued to labs that voluntarily choose to be inspected by an approved accrediting organization like COLA, CAP, or The Joint Commission.
- Benefits: May offer faster accreditation or combined oversight for facilities seeking multiple certifications.
Test Complexity Categories
Under CLIA, tests are grouped by their complexity, as this affects certification requirements.
Waived Tests
These are simple, easy-to-administer tests with minimal risk. Manufacturers submit data to the FDA to classify a test as waived. Labs performing only these tests need a Certificate of Waiver.
Moderate-Complexity Tests
These include a wider array of tests, including some automated chemistry panels. Labs performing these tests must meet personnel standards, have documented quality systems, and be subject to inspections.
High-Complexity Tests
These are complex laboratory-developed tests (LDTs) or tests requiring significant interpretation. Labs performing high-complexity testing face the strictest personnel, proficiency, and quality control standards.
CLIA Fees and Application Process
Application
The CLIA application (Form CMS-116) requires labs to disclose:
- Type and volume of testing
- Ownership structure
- Contact and location information
- Type of CLIA certificate requested
Fees
CLIA fees are assessed biennially and vary based on:
- Certificate type
- Test volume
- Test complexity
As of recent data, fees range from a few hundred dollars for waived labs to several thousand for large high-complexity laboratories.
CLIA-Waived Instant Drug Tests
A CLIA-waived test refers to a laboratory test that has been approved by the Food and Drug Administration (FDA) for use in non-complex laboratory settings and has been designated as “waived” under the CLIA program. These tests are classified as simple, low-risk procedures that can be performed with minimal training and a low likelihood of producing erroneous results when administered according to the manufacturer’s instructions.
Characteristics of CLIA-Waived Tests:
– Simple to perform with step-by-step instructions
– Require no specialized instrumentation or interpretation
– Often include point-of-care (POC) tests, such as fingerstick glucose tests, rapid strep tests, influenza swabs, and urine tests
Examples of commonly used CLIA-waived tests include:
– Rapid COVID-19 antigen tests
– Hemoglobin A1c tests
– Fecal occult blood tests
– Urine dipsticks
– Cholesterol screening kits
The popularity of CLIA-waived tests has surged, particularly in urgent care centers, retail pharmacies, mobile clinics, and physician offices, where there is a need for quick, on-site diagnostic information.
To legally perform CLIA-waived tests, facilities must apply for and obtain a CLIA Certificate of Waiver from the CMS. Though these facilities are not routinely inspected, they are expected to:
– Follow all manufacturer instructions precisely
– Maintain records of test usage, results, and quality control
– Undergo inspection if there are complaints or signs of noncompliance
Many healthcare providers rely on insurance reimbursement for routine testing services, including CLIA-waived instant tests. However, for a test to be reimbursed, specific billing, coding, and regulatory conditions must be met.
Key Requirements for Reimbursement:
CLIA Number on Claim Forms
To be eligible for reimbursement, providers must include their **CLIA certificate number** on claim forms (e.g., CMS-1500 or electronically via the 837P). This number links the performing site to a valid CLIA certificate.
Use of Approved CPT/HCPCS Codes
Only tests that are FDA-approved and CLIA-waived will have designated CPT (Current Procedural Terminology) codes or HCPCS (Healthcare Common Procedure Coding System) codes. These codes must reflect the exact test performed.
Example:
– 87880: Rapid Strep A test (CLIA-waived)
– 82962: Glucose, blood by glucose monitoring device(s) cleared by the FDA
Diagnosis Justification (ICD-10 Codes)
A medically necessary diagnosis code must accompany the billing claim to show why the test was needed. Payers may deny claims if the diagnosis is not deemed appropriate for the test.
Correct Site of Service
Insurance plans and Medicare require that CLIA-waived tests be performed **only in locations with an active Certificate of Waiver**. Performing these tests in a non-certified location can result in claim denials.
National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs)
Medicare and some private payers publish coverage policies outlining the circumstances under which they will reimburse for specific lab tests. Providers must ensure their use of the test complies with these guidelines.
Additional Tips for Reimbursement:
– Keep documentation of manufacturer’s waiver status for each test used.
– Maintain a comprehensive audit trail for all performed and billed tests.
– Stay current with payer policies, as some insurers periodically update reimbursement rules for waived tests.
Medicare and Medicaid Reimbursement
CLIA-waived tests are generally reimbursed by Medicare and Medicaid, provided that all compliance requirements are met. Some Medicaid programs may have additional state-specific rules, such as requirements for managed care organizations (MCOs).
The Clinical Laboratory Improvement Amendments (CLIA) form the backbone of laboratory regulation in the United States. By ensuring consistent quality and standardization, CLIA plays a critical role in the accuracy of medical diagnoses and treatments. Whether it’s a small physician’s office or a national reference laboratory, all testing sites are held to standards that protect patient safety and support clinical care.
References
- Centers for Medicare & Medicaid Services (CMS). CLIA Overview
- Centers for Disease Control and Prevention (CDC). CLIA Laboratory Program
- U.S. Food & Drug Administration (FDA). CLIA Waiver Program
- COLA, Inc. Understanding CLIA Requirements
- American Association for Clinical Chemistry (AACC). What is CLIA?
- Photo by Logan Gutierrez on Unsplash