Virginia Clinical Laboratory Requirements

Virginia does not require a separate state clinical laboratory license or state clinical laboratory personnel license. According to the Virginia Department of Health, clinical laboratories operating in the Commonwealth are regulated under the federal CLIA program. The Virginia Department of Health (VDH) administers the federal CLIA program in Virginia, and the state has more than 6,850 federally certified CLIA laboratories. Laboratories must also comply with applicable Virginia laws governing specific laboratory activities, including the Lyme disease test-result notification requirement under Va. Code § 32.1-137.06 and the communicable-disease reporting duties described below.

Scope of this guide

This guide addresses a typical independent commercial clinical laboratory testing human specimens; it is not a legal opinion or final facility-opening checklist. Facility licensure, personnel licensure, hospital/facility rules, out-of-state testing permits, payer enrollment, and specialty rules are separate questions — confirm each with the state authority. This guide addresses the general independent clinical laboratory model; it is not a determination of every possible specialty-specific, local, environmental, occupational, or healthcare-facility requirement. Before relying on this guide, verify with the state: ownership/facility type, testing complexity and specialties, whether specimens are collected or tested in-state, whether tests are sent out of state, and whether personnel licenses are required.

State agency

Virginia Department of Health (VDH), Office of Licensure and Certification — Division of Acute Care Services, CLIA Program — Virginia's CLIA survey agency (per VDH's laboratories page and CMS's CLIA State Agency Contacts (PDF)):

  • 9960 Mayland Drive, Suite 401, Henrico, VA 23233 (mail: ATTN: CLIA Program)
  • Phone: (804) 367-2107 · Fax: (804) 527-4504
  • Email: CLIAlab@vdh.virginia.gov

An important clarification: the Office of Licensure and Certification administers only four state facility-licensing programs — hospitals, nursing homes, home care, and hospices (VDH OLC overview) — and clinical laboratories are not among them.

Facility requirements

Virginia does not require a separate state clinical laboratory facility license. VDH evaluates laboratories under the federal Clinical Laboratory Improvement Amendments of 1988, not under any Virginia facility license. The fact that the same office licenses hospitals, nursing homes, home care, and hospices sometimes causes confusion — none of those four programs applies to laboratories.

Facility-type notes

Virginia does not establish a separate clinical laboratory licensing category based on whether testing is performed in an independent laboratory, physician office, hospital, or nursing home. However, healthcare facilities remain subject to their applicable facility-specific licensing and operational requirements. For example, licensed hospitals must meet the clinical laboratory service requirements under 12VAC5-410-300, which requires hospitals to provide hematology, chemistry, microbiology, seroimmunology, clinical microscopy, and other necessary laboratory services either directly or through a contractual arrangement with a reference laboratory. This does not create a separate clinical laboratory license — it is a hospital facility requirement. The difference between settings is the federal certificate type, which follows test complexity:

  • Waived-only testing (common in physician offices and clinics) — Certificate of Waiver.
  • Physician-performed microscopy — Certificate for Provider-Performed Microscopy (PPM).
  • Moderate- and high-complexity testing (typical of independent and hospital labs) — Certificate of Registration, then Certificate of Compliance (state-agency survey) or Certificate of Accreditation (through a CMS-approved accrediting organization such as CAP or COLA).

What federal CLIA requires

The governing federal framework is the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, and 42 CFR Part 493 — Laboratory Requirements. Laboratories testing human specimens for diagnosis, prevention, or treatment of disease generally require CLIA certification, subject to specified exceptions.

  • A CLIA certificate for the testing your lab performs — apply on Form CMS-116, CLIA Application for Certification (PDF). VDH requires CLIA applications to be submitted by postal mail with an original director signature to the CLIA Program address above; CLIA questions go to CLIAlab@vdh.virginia.gov. Do not confuse the application mailing address with the separate payment mailing instructions shown in the VDH FAQs.
  • A laboratory director and qualified personnel for your test complexity — see Zilgene's personnel reference pages below.
  • Proficiency testing, quality control, and quality assessment — under 42 CFR §§ 493.801 and 493.803, laboratories performing nonwaived testing must participate successfully in CMS-approved proficiency testing for applicable regulated specialties, subspecialties, and analytes. For tests not covered by an applicable proficiency-testing requirement, laboratories must establish and maintain the accuracy of their testing procedures using the applicable alternative assessment requirements.
  • A controlled test menu.

Certificate types:

  • Certificate of Waiver — waived testing only.
  • Certificate for Provider-Performed Microscopy (PPM) — authorized PPM procedures and waived testing.
  • Certificate of Registration — initial authorization for moderate/high-complexity testing while awaiting the required survey or accreditation determination. This is an interim certification stage, not a permanent certificate option.
  • Certificate of Compliance — issued following a successful CLIA state-agency survey.
  • Certificate of Accreditation — issued based on accreditation by a CMS-approved accreditation organization.

Personnel requirements

Virginia does not require a separate state clinical laboratory personnel license. Personnel qualifications are governed by federal CLIA requirements. Laboratories performing moderate- or high-complexity testing must meet the applicable education, training, experience, and competency requirements under 42 CFR Part 493, Subpart M. PPM laboratories are subject to their separate federal personnel requirements (42 CFR §§ 493.1351–493.1365). Waived testing is subject to the applicable CLIA requirements but does not impose the same federal personnel qualification standards as nonwaived testing.

CLIA positions differ by test complexity:

CLIA position Moderate complexity High complexity
Laboratory Director (LD) Yes Yes
Clinical Consultant (CC) Yes Yes
Technical Consultant (TC) Yes No
Technical Supervisor (TS) No Yes
General Supervisor (GS) No Yes
Testing Personnel (TP) Yes Yes

See Zilgene's personnel reference pages:

Virginia-specific laboratory reporting requirements

Lyme disease test-result notification

Under Va. Code § 32.1-137.06, every laboratory reporting the results of a Lyme disease test ordered in an office-based setting by a healthcare provider must include the following notice with the results reported to that provider:

PATIENTS UNDERGOING A LYME DISEASE TEST SHOULD BE AWARE THAT LYME DISEASE TESTS VARY AND MAY PRODUCE RESULTS THAT ARE INACCURATE. THIS MEANS A PATIENT MAY NOT BE ABLE TO RELY ON A POSITIVE OR NEGATIVE RESULT. HEALTH CARE PROVIDERS ARE ENCOURAGED TO DISCUSS LYME DISEASE TEST RESULTS WITH THE PATIENT FOR WHOM THE TEST WAS ORDERED.

This is a statutory requirement, not a VDH recommendation. Laboratories performing applicable Lyme disease testing must incorporate this notification into their result-reporting workflow.

Communicable disease reporting

Although Virginia does not require a separate state clinical laboratory license or personnel license, clinical laboratories must comply with applicable disease-reporting requirements. Under Va. Code § 32.1-36 and 12VAC5-90-80 and 12VAC5-90-90, laboratory directors must report specified laboratory findings indicative of reportable diseases and conditions to the appropriate local health department. Examples include Chlamydia trachomatis, Neisseria gonorrhoeae, Lyme disease, tuberculosis and other mycobacterial diseases, influenza, hepatitis, Salmonella and other specified enteric pathogens, and certain antimicrobial-resistant organisms.

Reporting deadlines vary depending on the organism or condition. Certain findings require immediate notification by the most rapid means available, preferably by telephone, while others must generally be reported within three days. Some positive findings also require submission of isolates or specimens to the Virginia Division of Consolidated Laboratory Services or another designated public health laboratory — the initial isolate (preferred) within five days or the clinical specimen within two days of a positive result. Laboratories should maintain procedures for identifying reportable results, submitting required reports, and documenting compliance with Virginia's disease-reporting regulations. The regulations were amended effective September 10, 2025 — use the current version rather than older disease-reporting lists. See VDH: Conditions Reportable by Directors of Laboratories (PDF).

Forms and references

  • Form CMS-116 — CLIA Application for Certification (PDF) — your CLIA certificate application; VDH requires postal-mail submission with an original director signature (9960 Mayland Drive, Suite 401, Henrico, VA 23233, ATTN: CLIA Program).
  • Form CMS-209 — Laboratory Personnel Report (PDF) — revised September 2025, applicable to moderate- and high-complexity laboratories. Maintain an accurate and current personnel report identifying individuals performing CLIA-regulated testing functions and their assigned positions. Keep the supporting qualification, experience, training, and competency documentation available for inspection.
  • Updated Lab Test Menu — a controlled laboratory document listing every test by specialty; surveyors cross-check it against the certificate. It is not a separate state test-menu submission.
  • CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines.
  • Zilgene FAQ — common CLIA and certification questions, answered.

Inspection preparedness

Surveyors working through VDH's Office of Licensure and Certification verify that the specialties, sites, and director on your CMS-116 match current operations, that your CMS-209 personnel roster is current, and that your test menu is controlled and matches the certificate. For independent laboratories performing moderate- or high-complexity testing, have these inspection-preparedness documents ready:

  • Current CLIA certificate and approved specialties.
  • Current Form CMS-209, where applicable.
  • Laboratory director and personnel qualification files.
  • Current controlled test menu.
  • Proficiency testing records and corrective actions.
  • Quality control and quality assessment documentation.
  • Test validation and verification records.
  • Standard operating procedures.
  • Equipment maintenance and calibration records.
  • Personnel competency assessments.

The federal inspection framework is 42 CFR Part 493, including Subparts H, J, K, M, and Q. The scope of any given inspection depends on the laboratory's certificate type and the applicable survey circumstances — not every inspection reviews the same documents.

How Virginia differs from federal CLIA

Virginia layers no separate licensure on top of CLIA — meeting federal requirements is the compliance baseline. The differences are administrative and reporting-specific, not regulatory: CLIA applications go by postal mail with an original director signature to VDH's CLIA Program; effective March 1, 2026, laboratories and providers were required to transition to CMS email notifications to receive electronic CLIA fee coupons and certificates, and paper fee coupons and paper CLIA certificates are no longer available — keep your contact email current with CMS and the Virginia CLIA Program. On top of CLIA, Virginia labs carry state reporting duties: the Lyme disease test-result notification under Va. Code § 32.1-137.06 and communicable-disease reporting by laboratory directors under Va. Code § 32.1-36 and 12VAC5-90-80 and 12VAC5-90-90. And the one thing to keep straight: VDH's Office of Licensure and Certification does license four kinds of facilities (hospitals, nursing homes, home care, hospices), but it evaluates laboratories under federal CLIA only — no Virginia lab license or personnel license sits alongside the CLIA certificate.

How Zilgene can help

Zilgene guides laboratories through CLIA certification, personnel qualification, and inspection readiness nationwide. Contact us for a free first consultation — every engagement is scoped and quoted upfront.

Official links

Last verified: November 2026