Form 3225, Application for Certification – Supplement to CMS 116

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Documents

Effective Date: 4/2021

 

Instructions

Updated: 4/2021

 

Purpose

Form 3225 is used as a supplement to the Centers for Medicare & Medicaid Services (CMS) Form CMS-116 (PDF) to apply for a Clinical Laboratory Improvement Amendments of 1988 (CLIA) program certificate. Contact Health Facility Compliance at INFOHFLC@hhs.texas.gov with any questions.

 

Procedure

When to prepare

The Texas Health and Human Services Commission (HHSC), on behalf of the CMS CLIA program, uses Form 3225 to process CLIA certificate applications. Applicants must forward a completed Form 3225 to their appropriate CLIA State Agency regional office for HHSC to accept and process their CLIA application. HHSC will not process Form 3225 applications until the CLIA State Agency regional office receives and approves all requested information.

CLIA information is located at: https://hhs.texas.gov/doing-business-hhs/provider-portals/health-care-facilities-regulation/laboratories-clinical-laboratory-improvement-amendments.

CLIA Background

CLIA requires all entities that perform even one test, including a waived test on "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings," to meet certain Federal requirements. If an entity performs any tests for these purposes, the entity is considered under CLIA to be a laboratory and must register with the CLIA program.

The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate CMS may issue and the fees CMS may assess.

A facility applying for CLIA certification must choose one of the following certification types:

  • Certificate of Waiver;
  • Certificate for Provider-Performed Microscopy (PPM) Procedures;
  • Certificate of Compliance; or
  • Certificate of Accreditation.

The requirements for each certificate are different and an applicant must include the appropriate documentation with each application.

For questions about the application process, contact the CLIA State Agency regional office (PDF). Forward completed documents to the appropriate CLIA regional office for the application to be accepted and processed. An application will not be processed until all requested information is received and approved by this office. For more information, see the CMS Certification Quick Start Guide (PDF).

Certificate of Waiver

A Certificate of Waiver allows a facility to perform only tests that are classified as waived. As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring. CMS maintains a complete list of waived tests.

A facility performing waived testing must follow the manufacturer’s instructions and have a current CLIA certificate. There are no qualification requirements for the laboratory director or testing personnel of a facility with a Certificate of Waiver.

An applicant must complete the registration process before CMS issues a Certificate of Waiver, to include:

  1. CLIA Application for Certification, CMS-116 (PDF); and
  2. Form 3225, Disclosure of Ownership.

Certificate for Provider-Performed Microscopy (PPM) Procedures

A Certificate for Provider-Performed Microscopy (PPM) procedures allows a facility to perform a limited list of tests requiring microscopic procedures. PPM tests are considered moderately complex; therefore, a facility must comply with CLIA regulations for moderate complexity testing. Examples of PPM testing include: wet mounts and potassium hydroxide preparations (also known as KOH preps). CMS maintains a complete list of PPM tests.

The director of a PPM facility must be a state-licensed physician, midlevel practitioner or dentist. When submitting an application for a PPM certificate, the facility must provide a copy of the facility director’s current Texas medical license, nursing license or dental license.

A facility with a PPM certificate type can also perform waived tests.

An applicant must complete the registration process before CMS issues a Certificate for PPM, to include:

  1. CLIA Application for Certification, CMS-116 (PDF);
  2. The required personnel qualifications for a Certificate for PPM including verification of state licensure; and

    Note: The CMS State Operations Manual, Appendix C (PDF) contains a complete list of CLIA personnel qualifications requirements.
     
  3. Form 3225, Disclosure of Ownership.

Certificate of Compliance

A Certificate of Compliance allows a facility to conduct moderate and/or high complexity testing.

The director of a facility with a Certificate of Compliance must be qualified to oversee non-waived testing. When submitting an application for a Certificate of Compliance, or when changing the laboratory director, the facility must also submit documentation of the director’s qualifications.

In addition to moderate and high complexity testing, a facility with a Certificate of Compliance can also perform PPM and waived testing.

An applicant must complete the registration process before CMS issues a Certificate of Compliance, to include:

  1. CLIA Application for Certification, CMS-116 (PDF);
  2. The required personnel qualifications for a Certificate of Compliance to include:
    • Verification of state licensure (as applicable); and
    • Documentation of qualifications:
      • Education (copy of diploma, transcript from accredited institution, CMEs);
      • Credentials; and
      • Laboratory experience; and

        Note: The CMS State Operations Manual, Appendix C (PDF) contains a complete list of CLIA personnel qualifications requirements.
         
  3. Form 3225, Disclosure of Ownership.

Certificate of Accreditation

A Certificate of Accreditation allows a facility to conduct moderate and/or high complexity testing.

The director of a facility with a Certificate of Accreditation must be qualified to oversee non-waived testing. When submitting an application for a Certificate of Accreditation, or when changing the laboratory director, the facility must also submit documentation of the director’s qualifications. During the initial application process, the facility must select a specific Accreditation Organization (AO) on the CLIA application and provide evidence of enrollment with the AO.

In addition to moderate and high complexity testing, a facility with a Certificate of Accreditation can also perform PPM and waived testing.

Applicants for a Certificate of Accreditation must provide evidence of enrollment with one of the seven CMS approved AOs: AABB, American Association for Laboratory Accreditation, Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (AAHHS/HFAP), American Society for Histocompatibility and Immunogenetics, COLA, College of American Pathologists, and Joint Commission.

An applicant must complete the registration process before CMS issues a Certificate of Accreditation, to include:

  1. CLIA Application for Certification, CMS-116 (PDF);
  2. The required personnel qualifications for a Certificate of Accreditation to include:
    • Verification of state licensure (as applicable); and
    • Documentation of qualifications:
      • Education (copy of diploma, transcript from accredited institution, CMEs);
      • Credentials; and
      • Laboratory experience; and

        Note: The CMS State Operations Manual, Appendix C (PDF) contains a complete list of CLIA personnel qualifications requirements.
         
  3. Form 3225, Disclosure of Ownership; and
  4. Enrollment letter from an approved AO.

Fees

Do not send payment for CLIA fees to HHSC. Follow the instructions on the user fee coupon generated by CMS to make a payment.

When submitting a check, always include the CLIA ID number.

Fees for certificates are billed biennially. The amount is based on certificate type (for Certificates of Waiver and PPM) and the annual volume of testing and number of laboratory specialties performed (for Certificates of Compliance and Accreditation).

For more information, visit the CMS CLIA Certificate Fee Schedule.

To make a payment online, CMS utilizes Pay.gov.