Government legislation and CLIA

Government legislation affecting clinical laboratory testing

In 1988 Congress passed the Clinical laboratory improvement amendments (CLIA). This law established quality standards for all clinical laboratory testing, and it is designed to ensure the accuracy, precision, reliability, and timeliness of patient test results, regardless of which laboratory performed the testing. A clinical laboratory is defined as any facility that performs laboratory testing on human specimens to provide information about the diagnosis, prevention, and treatment of disease or the impairment of health.

Clinical laboratory improvement amendments

Under CLIA, all laboratories that perform even one type of test must meet certain federal requirements. They must register with the Centers for Medicare and Medicaid services (CMS) as a laboratory. The registration application must be submitted to the CMS with information about the laboratory’s operations. The type of certificate that is issued is based on the information provided in the application. (Note that most POLs are registered as CLIA-waived laboratories.)

The US Food and drug administration (FDA) is responsible for categorizing commercially marketed tests performed in vitro based on the CLIA guidelines. The FDA has assumed primary responsibility for determining the CLIA complexity of all laboratory tests. Every laboratory test product is assigned to one of three CLIA categories based on the product’s potential risk to public health. The CLIA categories are as follows: waived tests, moderate-complexity tests, and high-complexity tests.

Category	Where it’s typically performed	Who may perform it
Waived	POLs, and some home settings	Any trained staff, including medical assistants
Moderate-complexity	POLs, hospitals, reference laboratories	Qualified personnel meeting CLIA’s requirements (may include medical assistants with added training)
High-complexity	Hospitals, reference laboratories	Personnel meeting CLIA’s most rigorous requirements (not medical assistants)

CLIA-waived tests and laboratories

CLIA-waived tests are defined as laboratory tests and procedures that have been approved by the FDA for home use or that are simple laboratory tests and procedures to perform. Waived tests are designed to have straightforward directions and procedures, so they have a minimal risk of incorrect results. Waived tests include tests that do the following:

• Use methodologies that are simple and accurate so that the likelihood of incorrect user results is negligible
• Pose no unreasonable risk of harm to the patient if it is performed incorrectly

Moderate- and high-complexity tests and laboratories

The CLIA program oversees the quality of nearly 200,000 laboratory procedures. Most laboratory tests are categorized by the FDA as moderate-complexity tests. Some moderate-complexity tests performed in POLs include the following:

• Hematology and chemistry: testing done on an automated analyzer
• Microbiology: Gram stain procedures
• Urinalysis: microscopic urinalysis

Moderate-complexity tests must be performed by qualified personnel as described by CLIA. High-complexity tests are generally not performed in a POL but rather in a hospital or reference laboratory.

Laboratories that perform moderate- to high-complexity testing must meet rigorous CLIA regulations and are subject to surprise inspections every 2 years. Each laboratory that performs these tests must do the following:

• Establish a system to maintain the identification of patients’ specimens throughout the testing process and ensure accurate reporting of results.
• Establish and follow written quality assurance (QA), quality control (QC), and standard operating procedures (SOPs).
• Participate in proficiency testing, which is a form of external quality control. Three times a year, the laboratory must test samples provided by an approved proficiency-testing agency. The proficiency samples are tested in the same way as patient samples. Results are then reported to the proficiency-testing agency, and the accuracy of testing is verified. The College of American pathologists (CAP) is an accrediting body for laboratories that offers proficiency testing.
• Employ personnel that meet CLIA regulations and specific qualifications for a moderate- to high-complexity laboratory. Requirements are most rigorous for high-complexity testing.

Medical assistants can perform all CLIA-waived tests and some specific moderate-complexity tests. Additional training will be required to perform moderate-complexity tests, depending on the certification of the POL where the medical assistant works. Although medical assistants cannot perform high-complexity tests, they can be involved in patient preparation, provider-directed patient education, specimen collection, and documenting results in the patient’s health record. CLIA sets the complexity category for a test, but state law and the state medical board’s scope-of-practice rules determine whether a medical assistant may actually perform it - so the controlling authority is the state statute, not the CLIA category or an employer’s job description.