CMS-116 Form: How to Fill It Out

Download the current edition from CMS. It is a fillable PDF: type your answers and save it. The footer of every page should read Form CMS-116 (03/24), and the paperwork notice on page 1 gives OMB No. 0938-0581, expiration 03/31/2027. (CMS's forms page shows those two dates swapped; the form itself is the one to trust.)

Have these to hand before you open it:

• Your certificate type. If you are unsure, the CLIA certificate finder decides it in four questions.
• Every test you run or plan to run: analyte, test name, manufacturer, and for non-waived tests whether it is moderate or high complexity (the FDA database has each categorization).
• An estimated annual volume for each specialty.
• The federal tax ID, and an email address the whole lab can read.
• For any non-waived certificate, PPM included, the director's proof of qualifications: state licence where applicable, diploma or transcript, credentials and lab experience. A foreign degree needs an equivalency evaluation.

CMS estimates an hour to complete it. Check with your State Agency first: some states add their own licence and forms, and labs in Washington and New York start with the state programs CMS lists.

I. General information

Tick one reason: initial application, survey (an initial survey or a recertification), change in certificate type, change in laboratory director, or other changes such as a new location or a closure. A first application gives an anticipated start date; a change gives the date it takes effect.

• CLIA number. Leave it blank on a first application; one is assigned. On anything else, copy it from your certificate. The instructions call it “10 digit”, but the third character is always the letter D (what the format tells you): a made-up example is 12D3456789.
• Facility name. Be specific. What you write here is what appears on the certificate.
• Email. Tick “receive notifications including electronic certificates via email” and the address is required. The fee notice and the certificate arrive there.
• Addresses. The facility address is where testing happens and cannot be a P.O. box or mail stop. Mailing and corporate addresses are optional; pick which of the three receives the fee coupon and which receives the certificate.
• Director. Name (last, first, initial), phone and credentials.

II. Type of certificate requested

Check only one, matching the highest complexity you perform. The box tells you how much of the form to fill: waiver labs complete Sections I to VI and IX to X, PPM labs I to VII and IX to X, compliance and accreditation labs all of I to X. An accreditation applicant also ticks its accreditor (The Joint Commission, AABB, A2LA, ACHC, CAP, COLA or ASHI; see the CMS-approved list) and must show accreditation, or an application for it, within 11 months of receiving its registration certificate.

III. Type of laboratory

One code from 01 to 29 for the setting where testing happens: 21 physician office, 15 independent, 14 hospital, 20 pharmacy. Dentists and chiropractors use 22 practitioner other. A mobile laboratory (19) attaches the VIN of every vehicle.

IV. Hours of laboratory testing

Only the hours when testing actually happens, in HH:MM. The instructions say not to use military time; tick 24/7 if it applies.

V. Multiple sites

One certificate can cover several sites only under three exceptions: a lab with no fixed location (mobile units, health fairs), limited public health testing by a not-for-profit or government lab (no more than 15 moderate complexity or waived tests per certificate), or hospital labs on one campus under common direction (§ 493.35(b), § 493.55(b)). Otherwise each location files its own form.

VI. Waived testing

List each waived analyte with its test name and manufacturer (the form's example: Streptococcus group A, a rapid strep kit, its maker), then one estimated total for all waived tests. Waiver-only labs stop here and skip VII and VIII. Dipstick urinalysis belongs in this section.

VII. PPM testing

Tick each provider-performed microscopy procedure you do from the nine on the form: wet mounts, KOH preps, pinworm exams, fern tests, post-coital exams, urine sediment, nasal smears for granulocytes, fecal leukocytes and qualitative semen analysis. Give their total volume. A compliance or accreditation lab also carries this volume into Section VIII.

VIII. Non-waived testing

List each non-waived test with its manufacturer and an M (moderate) or H (high). Then tick each specialty or subspecialty, each with a three-digit code (routine chemistry 310, urinalysis 320, hematology 400, bacteriology 110), and enter its estimated annual volume and, for accreditation, the accreditor beside it. A multi-site certificate counts all sites.

The volume rules are on the form: leave out tests not subject to CLIA, waived tests, and tests run “for quality control, calculations, quality assurance or proficiency testing”. Count each analyte of a panel (§ 493.638(c)(1)); the form's lipid panel counts as 4. The instructions add rules by specialty: a culture once per request per specimen, histopathology by block, cytology by slide, a WBC differential as one.

This total is what sets a compliance or accreditation lab's fee schedule under § 493.638(c)(3). The CLIA fee calculator turns it into CMS's two-year bill.

IX. Type of control

One box: voluntary nonprofit (religious, private or other), for profit (proprietary), or government (city, county, state, federal, other). The form also asks whether a non-U.S. government or entity has partial or full ownership or control, and if so the country.

X. Director affiliation with other laboratories

List every other separately certified lab this director runs, waiver labs included, with its CLIA number. The instructions set the ceiling: for PPM, compliance or accreditation, one person can direct no more than five certificates.

The signature

The owner or director signs “in ink or use a secure electronic signature”, with printed names for both the director and the owner. The signature agrees to run the lab to CLIA's standards and to let HHS inspect it and its records “at any reasonable time”. For the form, an owner is anyone with any interest in the lab, except through publicly traded stock.

Form and instructions: Form CMS-116 (03/24), read 23 October 2026.

The note under the form's signature line: “Completed 116 applications must be sent to your local State Agency.” That is the agency for the state where the lab sits, found on CMS's State Agency contact list (updated May 2026), which gives each agency's address, phone and email. Ask the agency how it wants the form sent. A lab outside the U.S. emails CMS first to check its eligibility (see CMS's apply page).

1. The State Agency processes the form.
2. CMS emails a fee notice with your new CLIA number and the amount due: the certificate fee, plus the survey or validation fee where it applies. A compliance or accreditation applicant pays first for a registration certificate.
3. You pay on pay.gov by bank account (ACH), debit or credit card.
4. The certificate arrives by email after payment. You can begin testing once you receive it.

The CLIA number is ten characters. Under Claims Processing Manual Ch. 16, § 70.4: “Positions 1 and 2 contain the State code”, position 3 “contains the letter ‘D’”, and positions 4 to 10 are the number unique to your lab. The fee depends on your certificate and volume: see the CLIA fee calculator, and the full five steps in how to get a CLIA certificate.