Texas Clinical Laboratory Requirements

Texas does not require a separate state clinical laboratory facility license. The Texas Health and Human Services Commission (HHSC) administers the federal CLIA program on behalf of CMS through its Health Facility Compliance Unit. Laboratories performing testing covered by CLIA must obtain the appropriate federal CLIA certificate and comply with applicable federal laboratory requirements. Although Texas does not separately license clinical laboratories, laboratories remain subject to state-specific public health reporting and specimen-submission requirements administered by the Texas Department of State Health Services (DSHS).

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. 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

Texas Health and Human Services Commission (HHSC) — Health Facility Compliance Unit, CLIA Program — the CLIA state agency for Texas. HHSC processes CLIA certificate applications on behalf of the CMS CLIA program, and its Health Facility Compliance Unit staff inspect laboratories for CMS. Applications go to the CLIA regional office serving the lab's location.

Regional CLIA offices:

Central CLIA contact:

• Phone: (512) 438-5952 · Fax: (512) 438-5973

• Email: CLIA@hhs.texas.gov

• Mailing address: Texas Health and Human Services, Health Facility Compliance – CLIA, MSC 1979 – CLIA, P.O. Box 149030, Austin, TX 78714-9030

• HHSC CLIA program page — the program's official page, including the link to the current CLIA regional-office contact list

• Form 3225 — Application for Certification, Supplement to CMS-116 — certificate-type selection and disclosure of ownership

• Questions about Form 3225: Health Facility Compliance at INFOHFLC@hhs.texas.gov

Applying

Forward your completed application package to your HHSC CLIA regional office — the application is not processed until all requested information is received and approved by that office. HHSC distinguishes the required documentation by certificate type:

Do not send payment with the application. CMS bills CLIA fees after processing — biennially, based on certificate type (Waiver and PPM) or annual test volume and number of specialties (Compliance and Accreditation) — and the fee notification comes from CMS, not HHSC.

Electronic CLIA certificates. After March 1, 2026, paper CLIA fee coupons and paper CLIA certificates are no longer available. Laboratories must maintain an up-to-date email address with CMS to receive electronic fee coupons and certificates; update your email through your regional CLIA office or on the CMS-116.

Facility requirements

No Texas clinical-laboratory license, permit, or registration exists beyond CLIA certification — HHSC's own program page says laboratories are not state licensed. Operate on your federal CLIA certificate, matched to your test complexity.

Certificate types (per the official Form 3225 page):

• Certificate of Waiver — perform only tests classified as waived: simple examinations with an insignificant risk of an erroneous result (e.g., dipstick urinalysis, fecal occult blood, urine pregnancy tests, blood glucose monitoring; CMS maintains the full list). Follow the manufacturer's instructions and hold a current CLIA certificate. No specific federal CLIA qualifications are required for the laboratory director or testing personnel — but this does not eliminate the laboratory's responsibility for appropriate training, following test instructions, and maintaining reliable testing practices.
• Certificate for Provider-Performed Microscopy (PPM) — microscopy procedures performed by a physician, midlevel practitioner, or dentist during the patient's visit. PPM procedures are classified as moderate complexity, but the certificate is restricted to the specific procedures authorized under CLIA. HHSC requires the PPM laboratory director to be a state-licensed physician, midlevel practitioner, or dentist, and the application must include a copy of the director's current Texas medical, nursing, or dental license, as applicable.
• Certificate of Compliance — nonwaived testing, subject to on-site survey verifying compliance with CLIA regulations. HHSC requires documentation of the laboratory director's qualifications when applying and when changing the laboratory director.
• Certificate of Accreditation — nonwaived testing under a CMS-approved accreditation organization instead of direct federal inspection. Select the accrediting organization on the application and provide evidence of enrollment. The current CMS-approved accreditation organizations (CMS list, August 2025) are AABB, the American Association for Laboratory Accreditation (A2LA), the Accreditation Commission for Health Care (ACHC), the American Society for Histocompatibility and Immunogenetics (ASHI), COLA, the College of American Pathologists (CAP), and The Joint Commission — see CMS: List of Approved Accreditation Organizations Under CLIA (PDF). Note that HHSC's online Form 3225 instructions still mention AAHHS/HFAP; that portion of the state guidance is outdated relative to the CMS list.

Facility-type notes: independent lab vs. hospital-based lab vs. physician-office lab

Independent laboratories, hospital laboratories, and physician-office laboratories are subject to the applicable federal CLIA certification requirements. A separate Texas clinical laboratory license is not required. The federal CLIA certificate must cover the actual testing performed, and the multiple-site rules must be considered: under 42 CFR § 493.35 and applicable multiple-site provisions, certain locations may be covered under one certificate when the regulatory conditions are satisfied. Laboratories operating at multiple locations should evaluate the federal CLIA multiple-site provisions and confirm certificate coverage with the HHSC CLIA regional office.

• Independent clinical laboratories typically hold a Certificate of Compliance or Certificate of Accreditation and face routine biennial surveys.
• Hospital-based laboratories hold the same nonwaived certificates.
• Physician-office laboratories most often hold a Certificate of Waiver (waived tests only) or a Certificate for Provider-Performed Microscopy (PPM); both are federal CLIA categories with no extra Texas credential.

What federal CLIA requires

• A CLIA certificate for the testing your lab performs — apply on Form CMS-116, CLIA Application for Certification (PDF), plus the Texas package above to your HHSC CLIA regional office.
• A laboratory director and qualified personnel for your test complexity — see Zilgene's personnel reference pages below.
• Proficiency testing enrollment for regulated analytes, quality control and quality assessment programs, and a controlled test menu.
• Keep CMS-209 current — the Laboratory Personnel Report (PDF) roster of your director and testing personnel must match who is actually in the lab.
• Notify CMS or its designated state agency of changes — for laboratories holding a Certificate of Compliance, 42 CFR § 493.51 establishes a 30-day notification requirement for changes in ownership, laboratory name, laboratory location, laboratory director, and technical supervisor (for high-complexity laboratories). Laboratories must also notify within six months after adding a test in a specialty or subspecialty not listed on the certificate, or making specified changes to test methodologies. Laboratories should confirm the applicable notification procedures for their certificate type with HHSC. HHSC also specifically requests director qualification documentation when changing the laboratory director for Compliance and Accreditation certificates.
• Public-health reporting: laboratories are subject to Texas's notifiable-condition reporting requirements — see below.

Personnel requirements

Texas does not require a separate state license for clinical laboratory technologists or other laboratory testing personnel solely by virtue of their laboratory employment. Federal CLIA personnel qualification requirements under 42 CFR Part 493 apply to moderate- and high-complexity testing. An important exception concerns laboratories applying for a Certificate for Provider-Performed Microscopy (PPM): HHSC requires the laboratory director to hold an applicable Texas professional license as a physician, midlevel practitioner, or dentist. See Zilgene's personnel reference pages:

• Laboratory Director
• Technical Supervisor / Technical Consultant
• Clinical Consultant
• General Supervisor
• Testing Personnel
• Frequently Asked Lab Personnel Questions

Reportable diseases

Texas's disease-reporting rules are DSHS's, not HHSC's, under Texas Health and Safety Code Chapter 81 and Title 25, Texas Administrative Code, Chapter 97. Laboratories are required reporters.

Who must report. Under Texas Health and Safety Code § 81.042(d), the person in charge of a clinical or hospital laboratory must report laboratory findings that provide evidence of a reportable disease. The reporting jurisdiction depends on whether the test was requested by a physician: if requested by a physician, report to the jurisdiction where the physician's office is located; if not requested by a physician, report to the jurisdiction where the laboratory is located.

What and when. Report confirmed and suspected cases of the conditions on the current Texas Notifiable Conditions list (2026 list), plus any outbreak, exotic disease, or unusual group expression of disease that may be of public health concern. Deadlines: immediately for public-health emergencies, outbreaks, exotic diseases, and unusual group expressions; within one working day for conditions requiring a rapid public-health response; within one week for all other conditions. The 24/7 number for immediately reportable conditions is 1-800-705-8868.

Where. Report to your local or regional health department, as determined under § 81.042 above. Disease notification and specimen submission are separate processes — do not assume all conditions are reported directly to the central DSHS laboratory.

Electronic reporting. Texas DSHS operates the Texas National Electronic Disease Surveillance System (NEDSS) Electronic Laboratory Reporting (ELR) program to facilitate electronic submission of reportable laboratory results. Laboratories should establish the applicable reporting method with DSHS or their local health authority and follow the current reporting requirements for each condition — DSHS reporting instructions also recognize other reporting methods, including paper and telephone reporting where applicable. Texas is a dual-reporting state: the ordering facility retains its own reporting responsibility even when a commercial laboratory reports the result.

Isolate and specimen submission. Laboratories must submit specified isolates or specimens to the DSHS Laboratory Services Section when required by the current Texas Notifiable Conditions list and applicable laboratory submission instructions. These include organisms associated with anthrax, botulism, brucellosis, Candida auris, diphtheria, Shiga toxin-producing E. coli, listeriosis, meningococcal disease, plague, salmonellosis, tuberculosis, tularemia, vibriosis, and other specified conditions. Additional submission requirements apply to selected organisms, including VISA and VRSA — immediately report isolates of vancomycin-intermediate and vancomycin-resistant Staphylococcus aureus by calling (800) 252-8239 or faxing (512) 776-7616. Laboratories should consult the current DSHS submission instructions before shipping specimens; see the DSHS Notifiable Conditions page for the current list and submission details.

Submission address: Texas Department of State Health Services, Laboratory Services Section, 1100 West 49th Street, Austin, TX 78756-3199. Call (512) 776-7598 for specimen submission information.

HIV and STD reporting. Laboratories report STD/HIV results on the Notification of Reportable Laboratory Test Results form (STD-28) to the local reporting authority — syphilis test results within three working days, all other reportable STD results including HIV within seven calendar days. This is laboratory result reporting; provider case reporting uses a different form (STD-27), and the deadlines and responsibilities are not interchangeable. Laboratory reporting also includes all CD4 T-lymphocyte results, all HIV viral loads (detectable and undetectable), positive and negative HIV DNA/RNA virologic results for infants up to three years old, supplemental HIV and syphilis testing following an initially positive screening result regardless of the subsequent result, and HIV nucleotide sequences. Contact the Electronic Laboratory Report Coordinator at hivstd@dshs.texas.gov to learn more about reporting laboratory results electronically.

Forms and references

• Form CMS-116 — CLIA Application for Certification (PDF) — your CLIA certificate application.
• Form CMS-209 — Laboratory Personnel Report (PDF) — keep your personnel roster current for surveyors.
• Texas HHS Form 3225 — Application for Certification, Supplement to CMS-116 — Texas's supplement filed with the CMS-116 (certificate-type selection and disclosure of ownership).
• HHSC CLIA program page — the official program page and regional-office contacts.
• CMS: List of Approved Accreditation Organizations Under CLIA (PDF) — current CMS-approved accreditation organizations (August 2025).
• DSHS Notifiable Conditions — the current reportable-conditions list, reporting timeframes, and specimen-submission instructions.
• CMS State Operations Manual, Appendix C (PDF) — federal survey procedures and interpretive guidelines.
• Zilgene FAQ — common CLIA and certification questions, answered.

Inspection preparedness

HHSC Health Facility Compliance surveyors 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. Have these ready before the surveyors arrive:

• Current CLIA certificate.
• CMS-116 and applicable application records.
• Current laboratory test menu.
• CMS-209 personnel report, where applicable.
• Laboratory director qualification documentation — HHSC requires it for Compliance and Accreditation applications and when changing the director.
• Personnel education, experience, and competency records.
• Proficiency testing records and corrective actions.
• Quality control and quality assessment documentation.
• Validation and verification records.
• Standard operating procedures.
• Equipment maintenance and calibration records.
• Disease reporting and specimen submission documentation.

How Texas differs from federal CLIA

On substance, Texas layers no licensure on top of CLIA — HHSC says so directly — but the pathway is Texas-specific: applications run through HHSC's CLIA regional offices with a state supplement (Form 3225) and qualification documentation that varies by certificate type. The credential at the end of that paperwork is still the federal CLIA certificate. Two administrative points to keep current: since March 1, 2026, CLIA fee coupons and certificates are electronic only, so keep your email current with CMS; and on top of CLIA, Texas labs also carry DSHS disease-reporting duties (notifiable-condition reporting with immediate, one-day, and one-week tiers, isolate submission to the DSHS laboratory, and STD-28 reporting for HIV/STDs). Confirm facility-category and specialty-specific requirements with HHSC before relying on this.

How Zilgene can help

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

Official links

• HHSC — Laboratories, Clinical Laboratory Improvement Amendments
• Texas HHS: Form 3225, Application for Certification — Supplement to CMS-116
• CMS: List of Approved Accreditation Organizations Under CLIA (PDF)
• DSHS: Notifiable Conditions
• CMS CLIA State Agency Contacts (PDF)

Last verified: November 2026