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CLIA Certificates

Pricing Schedule

A la carte services with transparent pricing. Choose exactly what you need.

Who we serve

White Glove CLIA prepares CLIA certificates, changes and state lab filings for practices, pharmacies, urgent care groups, telehealth companies and other testing sites. Your owner or director signs every application, and you pay CMS and the state directly. We never serve as laboratory director. Adding your CLIA number to payer files is handled by our White Glove Credentialing sister team.

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CLIA Readiness Review

$149 one-time

Which certificate you need, whether every test on your menu is FDA-categorized as waived, your state's add-on, whether any site fits a multiple-site exception, and your director's eligibility. Credited in full toward your first filing when you go ahead.

Certificate typeTest menu checkState add-onsCredited if you go ahead

Certificates

Certificate of Waiver Application

$399 per site

The CMS-116 with your test menu built from each kit's instructions, any state supplement such as Texas Form 3225, and a checklist. Your owner or director signs; we can send it to the State Agency. You pay CMS from your own emailed coupon.

CMS-116 preparedTest menu from the IFUsState supplementCoupon walkthrough

Waiver Application with Compliance Binder

$549 per site

The waiver application plus a compliance binder: an instructions-for-use log, the CDC waived testing self-assessment, and competency and quality control record templates.

Everything in the waiverIFU logCDC self-assessmentRecord templates

PPM Certificate Application

$599 per site

For practices doing provider-performed microscopy. Adds the director's qualification documents to the CMS-116.

CMS-116 preparedDirector documentsPPM procedures listedState supplement

Nonwaived Certificate Application Packet

$1,499 per lab

The CMS-116 for a Certificate of Registration on the way to compliance or accreditation, with the specialty table and the director's qualification documents. Quality systems and directors are not included.

CMS-116 for nonwaivedSpecialty volumesDirector documentsAccreditor coordination

Multiple Sites

Multi-Site Waiver Package, 5 Sites

$1,599 for five sites

Five Certificate of Waiver applications for a practice group, pharmacy chain or urgent care group, prepared together. Each site still pays its own CMS fee.

Five sitesOne test menuPrepared togetherOne tracking calendar

Multi-Site Waiver, 10 or More Sites

$249 per site

The same work for rollouts of ten or more sites.

Ten sites or morePrepared togetherPer-site filesOne tracking calendar

State Requirements

State Lab Registration

$299 per state

Short state filings on top of CLIA: California's registration, New York's Limited Service Laboratory registration, Washington's Medical Test Site license and similar.

Requirement confirmedApplication preparedOwner or director signsTracked to approval

State Lab License or Permit

$699 per state

Full state lab licenses and permits, such as Pennsylvania's permit or a Kentucky or Maine license, prepared for the owner or director to sign.

Requirement confirmedApplication preparedDirector documentsTracked to approval

Changes and Tracking

CLIA Change Request

$149 per change

A new director, address, name or test, prepared on the CMS-116 within the 30-day notice window, or before you start a new test.

30-day noticeCMS-116 changeState notice tooConfirmation tracked

Change of Ownership

$299 per lab

The CLIA and state notices for a sale or ownership change, with any new application a state requires.

Ownership noticeState requirementsNew applicationsConfirmation tracked

Renewal and Compliance Tracking

$299 per year

Your fee coupon and renewal dates watched, invoices checked against CMS and your State Agency, change reminders and state renewals, for your first lab.

Coupon watchInvoice checkChange remindersState renewals

Additional Site Tracking

$99 per year

The same tracking for each added site.

Per siteSame calendarCoupon watchState renewals

Important Fee Notice

(Prices above do not include the following)

The prices listed above are our service fees only. Costs paid directly to third parties are set by others and change from time to time, so we confirm them at intake:

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817-518-1747
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