COVID-19 and Clinical Laboratories: Licensing Requirements For Diagnostic Testing

Fox Rothschild LLP

Fox Rothschild LLP

Clinical laboratories across the country have ramped up their diagnostic testing capabilities to meet the critical need for COVID-19 testing, which is essential to mitigating the spread of the virus. Many labs are responding to this unprecedented demand by testing specimens from different states and entering into arrangements with employers and other third parties to collect specimens. Despite provisions in recent federal laws and waivers[1] designed to make COVID-19 testing available and accessible on a widespread basis, labs must maintain compliance with federal and state laws.

CLIA: the Federal Floor

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) set forth certification and quality standards for clinical laboratories performing diagnostic tests on specimens.[2]

The Requirements

Pursuant to CLIA, any laboratory performing moderate or high complexity specimen tests must have either a CLIA certificate or be a CLIA-exempt laboratory.[3] The Food and Drug Administration (FDA) categorizes tests as moderate or high complexity based on certain criteria.[4] Most COVID-19 diagnostic tests are categorized as moderate or high complexity tests, which must be performed in a laboratory that meets CLIA requirements.[5]

A “laboratory” is defined as any facility that examines materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or assessment of health of human beings. Facilities that only collect or prepare specimens, or that only serve as a mailing service and do not perform testing, are not considered laboratories and do not have to meet CLIA requirements.

Obtaining a CLIA Certificate

To obtain a CLIA certificate, clinical laboratories must file an application for each individual laboratory location with the Department of Health and Human Services (HHS) and follow certain records and reporting requirements outlined in CLIA. CLIA provides limited exceptions for laboratories that meet one or more of the following requirements:

  1. Clinical laboratories that are not in a fixed location
  2. A nonprofit federal, state or local government laboratory engaged in public health testing
  3. Certain laboratories located within a hospital campus.

CLIA Exemptions

CLIA exempts laboratories licensed or approved by a state where the state licensure program is more stringent than CLIA and has been approved by the Centers for Medicare and Medicaid Services (CMS). [6] Clinical laboratories licensed by and operating in these approved states do not need a CLIA certificate, but they must comply with state licensing laws.

State Licensing Requirements

CLIA sets the floor for clinical laboratory licensing requirements, so state laboratory licensing laws may be stricter.

State laboratory licensing laws generally fall into one of three categories:

  1. States that require only a CLIA certificate
  2. States that require both a CLIA certificate and a state license
  3. States that only require a state license because they are exempt.

For example, Arizona law requires only a CLIA certificate for clinical laboratories operating in the state.[7] On the other hand, Pennsylvania law requires clinical laboratories to hold both a Pennsylvania state license and a CLIA certificate. Finally, Washington and New York are exempt under CLIA, meaning clinical laboratories in these two states must only obtain a state license.[8]

Clinical laboratories should check the state laboratory licensing laws for the state in which they operate.

Out-of-State Labs

States may also impose licensing requirements on clinical laboratories located outside their borders that are processing specimens collected inside the state. Pennsylvania, for example, requires out-of-state clinical laboratories soliciting or receiving specimens originating within Pennsylvania to have a valid Pennsylvania state license, even if they are not physically located in the state. Other states may impose separate requirements for out-of-state laboratories. For example, California law requires that out-of-state labs collecting specimens in California for high or moderate complexity testing must obtain an out-of-state license.[9] It is important for clinical laboratories operating across state lines to ensure compliance with state laboratory licensing laws for any state in which the specimens they process originated.

The Big Picture

State clinical laboratory licensing laws vary in their detail and complexity, as well as their interplay with CLIA.  This Alert does not provide an exhaustive list of all the laws and regulations of which clinical laboratories must be aware. For guidance on how your clinical laboratory or related business can comply with applicable state and federal laws, please contact us.

[2] 42 U.S.C. § 263a et seq.;  42 C.F.R. Part 493.

[3] 42 C.F.R. § 493.45.

[6] 42 C.F.R. 493.2.

[7] Ariz. Rev. Stat. Ann. § 36-462.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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