Does On-Site Employee Drug Testing Require a CLIA Certificate?

Employers that run drug tests in house often ask whether they need a CLIA certificate from CMS. The answer depends on why the test is done, not on the test itself. The FAQ on whether employers can drug test on site covers the general setup, and this answer covers the federal lab certification question.

The general rule. A laboratory under 42 CFR 493.2 examines human specimens to provide information for the diagnosis, prevention or treatment of disease or the assessment of health, and 42 CFR 493.3(a) requires it to hold a CLIA certificate unless an exception applies. Certificate types include a certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, and certificate of accreditation. Section 493.5 sorts tests into waived, moderate complexity and high complexity categories.

Exceptions that matter for drug testing. Section 493.3(b) excludes components or functions of laboratories that do testing for forensic purposes, research labs that do not report patient-specific results, and labs certified by SAMHSA that perform drug testing under SAMHSA guidelines, for those tests. SAMHSA certification is explained in certified laboratories.

Purpose controls. CMS letter S&C-08-35 (September 5, 2008) explains that drug testing done only for employment decisions, such as hiring or firing, is forensic and outside CLIA. The letter quotes the preamble to the CLIA rules: the determining factor is not the test itself, but the purpose for which the test is conducted. If results are used to refer, offer or make treatment available to the employee, the testing assesses health, and the site must get a CLIA certificate or stop that testing.

Mixed programs. CMS's guide on obtaining a CLIA certificate states that if even one test is used to assess health, the lab needs a certificate. An employer that runs forensic screening and also provides results to an employee assistance or treatment program should review how results are used.

Waived tests. Waived tests are simple tests with a low risk of an incorrect result, and the FDA decides which tests qualify. A site that needs CLIA coverage and performs only waived tests can hold a certificate of waiver and must follow the manufacturer's instructions (42 CFR 493.15).

State overlay. Some states run their own lab licensing. CMS notes that New York and Washington run their own HHS-approved laboratory programs, so a lab there may not need a federal CLIA certificate, though New York's exemption is partial. Many states also have drug testing statutes that limit on-site screening or require lab confirmation. Employers weighing an in-house testing program should check state law along with CLIA.

Rule changes. CMS has proposed updates to the CLIA rules, covered in the Learn Laws® news item on CMS CLIA updates.