CLIA Certificate of Waiver

A Certificate of Waiver is issued "to a laboratory to perform only the waived tests listed at § 493.15(c)", a list FDA extends test system by test system (§ 493.2). The test is the whole of it: a lab qualifies if every test it runs is waived, and "no others" (§ 493.15(c)). Which tests count, and how to look one up, is in CLIA-waived tests: what counts and how to check.

Physician offices are the largest group: 84,829 of the 233,448 waiver labs in CMS's September 2026 laboratory statistics are physician office labs.

• One certificate per location. Each location files its own application (§ 493.35(a)), with three exceptions: mobile and temporary sites under a home base, not-for-profit or government labs doing limited public health testing ("not more than a combination of 15 moderately complex or waived tests per certificate"), and hospital labs on one campus under common direction (§ 493.35(b)).
• A director, with no federal qualifications. CMS: "A laboratory with a CLIA Certificate of Waiver (CoW) must have a laboratory director. There are no federal education or experience qualifications required for the laboratory director." State law may set its own.
• No microscopy. A provider looking at a wet mount or a urine sediment needs the certificate for PPM procedures instead, which also covers waived tests.

The application is Form CMS-116, sent to the State Agency for your state with no payment. A waiver lab ticks "Certificate of Waiver" in Section II and completes Sections I–VI and IX–X, skipping VII (PPM) and VIII (nonwaived testing). The field-by-field walk-through is in CMS-116 form: how to fill it out, and the steps every certificate shares are in how to get a CLIA certificate.

Three things on the form matter more for a waiver lab than for others:

1. The test list. Section VI lists each waived test with its test name and manufacturer, then one estimated annual total. List every waived test you will run.
2. The signature. An owner or authorized representative attests that the lab will be run under CLIA's requirements (§ 493.35(c)(2)).
3. The email address. The fee notice and the certificate arrive by email, so use an inbox more than one person reads.

A waiver lab also agrees, as a condition of the certificate, to make records available and to permit announced and unannounced inspections (§ 493.35(d)). That clause is where the visits below come from.

CMS's fee schedule (updated 2024) lists $248 for a Certificate of Waiver, paid every two years. There is no survey fee, because there is no routine survey. Two smaller fees sit on the same row: $75 for a replacement certificate and $95 for a revised one.

You pay after the State Agency processes the form. CMS emails a fee notice that carries your CLIA number, you pay on pay.gov, and the certificate follows by email. Do not report patient results until you hold it.

CMS fee schedule, updated 2024, read 2026-10-23. Payment steps: CMS apply page.

A waiver lab is held to subpart B and to § 493.15(e) (§ 493.37(b)), plus the fee and inspection rules. Put together, the federal list is short:

Sources: § 493.15, § 493.35, § 493.37, § 493.39. The certificate lasts "no more than 2 years" (§ 493.37(e)).

The first line carries the weight. Following the insert covers the specimen, storage, timing, reading and the quality control it calls for; a skipped step breaks the rule, and a changed step means you are no longer running the waived system (what the insert sets).

What is not on the list: proficiency testing, CLIA competency assessment and federal personnel qualifications. CMS still calls competency checks "good laboratory practice" for waived testing (CMS competency brochure), and a short sign-off per tester per test is cheap insurance when a visit comes.

A waiver lab "is not subject to biennial inspections" (§ 493.1775(a)). But CMS or its agent, usually the State Agency, may inspect it "at any time during the laboratory's hours of operation" for four reasons (§ 493.1775(b)):

1. to check that testing is not an imminent and serious risk to public health;
2. to evaluate a complaint from the public;
3. to see whether the lab is testing beyond its certificate;
4. to collect information about whether the tests should be waived at all;

The fourth needs no complaint. CMS's manual calls these surveys random (SOM § 6140.4), and the MLN fact sheet lists "a need to collect information about waived tests" among the triggers. Neither publishes a rate or a schedule for such visits, so the safe reading is that any working day could bring one.

What a surveyor can ask for

The basic inspection rule applies to every certificate (§ 493.1773(b)): testing samples, interviewing staff, watching tests from specimen to report, entering every area the certificate covers, and copies of records. Records must be "accessible and retrievable within a reasonable time frame" (§ 493.1773(c)). For a waiver lab that means the certificate, a current insert for each test, the QC records the inserts call for, and a test list that matches what is on the bench.

One nonwaived test ends the waiver. A lab that wants to add one must meet the rules for a nonwaived certificate (§ 493.37(g)) and notify CMS before it performs and reports that test (§ 493.39(a)). The CMS brochure names the moves: from CoW to PPM, compliance or accreditation, and back to CoW when a lab drops its nonwaived menu.

Before you buy an analyzer, look it up: many systems for analytes you already run waived are moderate complexity (waived, moderate and high complexity testing sets out what each level asks). The change itself goes through a new CMS-116 (keeping a certificate current).