State filing guide
CLIA waiver application and requirements in North Carolina.
Ask about my application — no payment todayNorth Carolina retains signed CMS-116 submission by email to DHSR; screen separate HIV/PAP/mammography registrations and use current federal paperless payments.
Sources checked 2026-10-31 · next source check due 2026-11-30
Federal application procedure
These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.
Get the North Carolina CLIA waiver checklist by email
The federal CMS-116 steps, what North Carolina's official sources say, what to confirm for your facility, and the official links, in one email you can keep. Free.
What the official sources say
- DHSR directs initial applications to DHSR.CLIA@dhhs.nc.gov. CMS September 2026 directory corroborates phone (919) 855-4620 and mailing address 2713 Mail Service Center, Raleigh NC 27699-2713; neither consulted contact source lists an NC CLIA fax.
- DHSR FAQ 2 says no separate state laboratory or laboratory-personnel licensure. Its forms index separately lists HIV Testing, Mammography Screening and PAP Smear Screening registrations; applicability must be reviewed against the actual menu.
- HIV application is Form 4205 rev. 01.27.2025. The mammography-labeled link serves PAP content; PAP page 1 and page 2 have inconsistent form numbers/revisions. These forms are not routine COVID-office attachments.
- CMS-hosted CMS-116 is 03/24, expires 2027-03-31; section VI requests a total annual waived volume. A separate guide labeled November 2026 illustrates 04/2026, a source conflict for prefiling review rather than a selected replacement. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved.
- CMS requires electronic coupons/certificates and Pay.gov since March 1, 2026; DHSR legacy lockbox/check instructions and non-waived $100 registration text do not govern this waiver fee.
- No initial processing or certificate-issuance interval was found in the consulted NC material. Renewal billing intervals and CMS overnight payment processing are not an initial-approval promise.
Fees and timing
Federal Certificate of Waiver: $248 per two-year certificate, paid via Pay.gov after CMS emails the fee coupon; no payment with CMS-116. No separate routine state CLIA surcharge is identified on the reviewed DHSR fee page. Separate screening-registration notes state no fee at this time; that is not a blanket $0 for all state programs. No initial issuance SLA was found. Government fees remain separate from preparation-service fees.
Check my test menuWhat still needs confirmation for your facility
- 1For a case involving HIV testing or PAP/mammography services, confirm the separate registration applicability, correct application and revision; resolve the mammography/PAP link error before using that program.
- 2Confirm the accepted CMS-116 edition and signed-email attachment/signature format before dispatch; retain the existing CMS-116/email route until a confirmed change.
Frequently asked questions
What filing route does the cited North Carolina guidance describe?
North Carolina retains signed CMS-116 submission by email to DHSR; screen separate HIV/PAP/mammography registrations and use current federal paperless payments.
Which requirements are named in the cited North Carolina materials?
DHSR directs initial applications to DHSR.CLIA@dhhs.nc.gov. CMS September 2026 directory corroborates phone (919) 855-4620 and mailing address 2713 Mail Service Center, Raleigh NC 27699-2713; neither consulted contact source lists an NC CLIA fax. DHSR FAQ 2 says no separate state laboratory or laboratory-personnel licensure. Its forms index separately lists HIV Testing, Mammography Screening and PAP Smear Screening registrations; applicability must be reviewed against the actual menu. HIV application is Form 4205 rev. 01.27.2025. The mammography-labeled link serves PAP content; PAP page 1 and page 2 have inconsistent form numbers/revisions. These forms are not routine COVID-office attachments. CMS-hosted CMS-116 is 03/24, expires 2027-03-31; section VI requests a total annual waived volume. A separate guide labeled November 2026 illustrates 04/2026, a source conflict for prefiling review rather than a selected replacement. Rechecked 2026-11-09: the direct CMS download now serves Form CMS-116 (04/2026), OMB 0938-0581, expiration 04/30/2029, matching the November 2026 guide; the edition discrepancy observed on October 31 is resolved. CMS requires electronic coupons/certificates and Pay.gov since March 1, 2026; DHSR legacy lockbox/check instructions and non-waived $100 registration text do not govern this waiver fee. No initial processing or certificate-issuance interval was found in the consulted NC material. Renewal billing intervals and CMS overnight payment processing are not an initial-approval promise.
What do the sources establish about fees and timing in North Carolina?
Federal Certificate of Waiver: $248 per two-year certificate, paid via Pay.gov after CMS emails the fee coupon; no payment with CMS-116. No separate routine state CLIA surcharge is identified on the reviewed DHSR fee page. Separate screening-registration notes state no fee at this time; that is not a blanket $0 for all state programs. No initial issuance SLA was found. Government fees remain separate from preparation-service fees.
Does this page confirm CLIA approval or legal compliance in North Carolina?
No. This is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device. Verify every requirement with CMS, the FDA, and your state agency before testing.
Official sources behind this guide
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From test research to your North Carolina application
An analyte label does not confirm a device. The exact test system and the clinic’s state route need separate review before a filing scope or price can be confirmed.