Certify a Laboratory, Pap Smear, HIV Testing & Screening Mammography Service

Purpose: This procedure briefly describes the steps necessary to certify laboratories, pap smear, HIV testing and screening mammography services in North Carolina. The Medical Care Commission has rulemaking authority for laboratories performing pap smears and screening mammography services, per N.C. General Statutes 143B-165 (PDF, 15 KB). Rules in Title 10A of the North Carolina Administrative Code apply (10A NCAC 13M). HIV testing is done in accordance with rules adopted by the Commission for Health Services at 10A NCAC 42D, per N.C. General Statute 130A-148 (PDF, 18 KB).

Laboratories that need to be certified under the Clinical Laboratory Improvement Act follow a separate procedure.

Contacts: For questions regarding any part of this process, please contact the appropriate sections of the N.C. Division of Health Service Regulation:

Clinical Laboratories (CLIA) Branch 919-855-4620
Certificate of Need Section 919-855-3873

Procedures:

  1. Obtain a certificate if need, if necessary: Certificate of Need Section
    1. If proposing to develop a laboratory for pap smear, HIV testing, or screening mammography services, the applicant should first contact the Certificate of Need Section to obtain a determination of whether or not the proposal requires a certificate of need.
    2. The Certificate of Need Section makes its determination based on the proposed capital expenditure for the project. A copy of the determination will be sent to the Clinical Laboratory Improvement Branch.
  2. Obtain state certification: Clinical Laboratory Improvement Branch
    1. The applicant contacts the branch for an application period.
    2. The applicant completes and returns the needed forms.
    3. The branch issues a letter of certification for any combination of the certification categories if the application displays evidence that the facility is in compliance with applicable rules.