TX HHS Form 3225. Application for Certification Supplement to CMS 116

Form 3225 is an official supplemental document used as part of the Clinical Laboratory Improvement Amendments (CLIA) certification process in the United States. This form is completed in addition to CMS Form 116 and focuses specifically on disclosure of ownership and control for clinical laboratories seeking CLIA certification or maintaining their existing certification.

Its primary purpose is to ensure transparency regarding who owns, controls, or has a significant financial interest in a laboratory that performs clinical testing on human specimens.

Purpose of the Form and When It Is Required

Form 3225 is required when a laboratory applies for CLIA certification using CMS Form 116 and must disclose ownership and controlling interest information. It helps federal and state authorities evaluate compliance, accountability, and eligibility to operate under CLIA regulations.

You must submit this form if you are opening a new clinical laboratory, changing ownership, or updating ownership information that affects control of the laboratory. Laboratories with no ownership changes may not need to resubmit the form unless specifically requested by regulators.

Who Is Allowed to Complete This Form

The form must be completed by an authorized representative of the laboratory, such as the owner, managing partner, corporate officer, or another individual legally permitted to disclose ownership information on behalf of the entity.

Explanation of Each Section

Facility and Contact Information

This section identifies the laboratory facility and includes the facility name, date of completion, and contact details for the laboratory director’s office. It ensures regulators know which laboratory the ownership disclosure applies to.

Person Completing the Form

Here, the individual responsible for completing the supplement is identified. This creates accountability and allows regulators to follow up if clarification is needed.

Disclosure of Ownership – Identifying Information

This section collects core identifying details about the owner or laboratory, including the CLIA number, federal tax identification number, physical address, and contact information. Accurate data here is essential for linking the disclosure to the correct CLIA certification record.

Ownership and Controlling Interest

Applicants must list individuals or organizations with direct or indirect ownership or controlling interest in the laboratory. For organizations, an Employer Identification Number (EIN) is required. This section is critical for revealing hidden or indirect control structures.

Type of Entity

The form requires selection of the legal structure of the entity, such as sole proprietorship, partnership, corporation, unincorporated association, or another specified type. This helps regulators apply the correct compliance standards.

Corporate Directors (If Applicable)

If the laboratory is owned by a corporation, this section requires disclosure of directors’ names, addresses, and EINs. This ensures full transparency of corporate governance.

Authorized Representative Certification

The authorized representative must sign and date the form, certifying that the ownership information provided is accurate and complete.

Common Mistakes Applicants Make

• Failing to disclose indirect ownership or controlling interests
• Listing outdated ownership or address information
• Leaving EIN fields blank for organizational owners
• Submitting the supplement without CMS Form 116
• Not signing or dating the authorized representative section

Legal and Regulatory Context

Form 3225 is governed by the Clinical Laboratory Improvement Amendments (CLIA) and administered by the Centers for Medicare & Medicaid Services (CMS). Federal law requires transparency of ownership to prevent fraud, ensure accountability, and protect public health. Failure to disclose accurate ownership information can result in denial, suspension, or revocation of CLIA certification.

Practical Tips for Completing the Form

• Verify ownership details against corporate records before submission
• Include all individuals or entities with any level of control
• Use consistent names and addresses across CMS Form 116 and Form 3225
• Double-check EIN and CLIA numbers for accuracy
• Keep a signed copy for your compliance records

Real-Life Scenarios Where This Form Is Required

• A new diagnostic laboratory applying for its first CLIA certificate
• A laboratory that has added a new corporate investor or partner
• A change from sole proprietorship to a corporate structure
• A laboratory undergoing regulatory review after an ownership audit

Documents Commonly Submitted with This Form

• CMS Form 116 (CLIA Application)
• Corporate formation or partnership documents
• IRS documentation confirming EINs
• Ownership agreements or shareholder records

Frequently Asked Questions

Is Form 3225 required for all laboratories?

It is required when ownership or controlling interest must be disclosed as part of CLIA certification or updates.

Can this form be submitted on its own?

No, it must be submitted as a supplement to CMS Form 116.

What counts as a controlling interest?

Any individual or entity with direct or indirect authority over laboratory operations or finances.

Do nonprofit laboratories need to complete this form?

Yes, if they have owners, directors, or controlling entities that must be disclosed.

What happens if ownership changes after submission?

Updated ownership information must be reported to maintain compliance.

Micro-FAQ

• Purpose: Discloses laboratory ownership and control under CLIA.
• Who files: Authorized laboratory owners or representatives.
• When required: With CMS Form 116 or ownership changes.
• Attachments: CMS Form 116 and ownership records.
• Submitted to: CMS or designated CLIA state agency.

Related Forms

• CMS Form 116 – CLIA Application for Certification
• CLIA Certificate of Compliance Forms
• Laboratory Change of Ownership Notifications

Form Details

• Form Name: CLIA Application for Certification – Ownership Disclosure Supplement
• Form Number: 3225
• Issued By: Centers for Medicare & Medicaid Services (CMS)
• Region: United States
• Revision Date: April 2021