United States Centers for Medicare & Medicaid Services (CMS) - Division of Clinical Laboratory Improvement & Quality

Please Note

We are a service company that can help you file with the United States Centers for Medicare & Medicaid Services (CMS) - Division of Clinical Laboratory Improvement & Quality. We are not associated with this nor any other government agency. We offer paid services and software to help you file. You are not required to purchase our service to file - you may file directly with this agency without using our service.

Contact Information


Web: Home Name search
Email: LabExcellence@cms.hhs.gov

Licenses

We track the following licenses with the United States Centers for Medicare & Medicaid Services (CMS) - Division of Clinical Laboratory Improvement & Quality in order to provide compliance services to our clients. As a client, you see this and other Compliance Core™ data in License Manager in-line with your licenses.

A laptop placed on a desk with our License Manager software on display

United States Clinical Laboratory Improvement Amendments (CLIA) Certificate for Provider Performed Microscopy Procedures

Agency:United States Centers for Medicare & Medicaid Services (CMS) - Division of Clinical Laboratory Improvement & Quality
Law:

42 U.S.C. § 263a

Foreign Qualification is Prerequisite:No
Registered Agent (Special Agency) Required?No

Initial Registration

Form:

Form CMS 116: Clinical Laboratory Improvement Amendments (CLIA) Application for Certification

Agency Fee:

$240, invoiced after approval

Notes:

Applications should be submitted to the state agency which handles CLIA Certificate applications for the state in which your laboratory resides. See the list of CLIA State Agency Contacts for contact information.

Registration Renewal

Agency Fee:

$240

Due:

Biennially

Notes:

There is no renewal application, simply submit the fee after receiving the invoice.

United States Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation

Agency:United States Centers for Medicare & Medicaid Services (CMS) - Division of Clinical Laboratory Improvement & Quality
Law:

42 U.S.C. § 263a

Foreign Qualification is Prerequisite:No
Registered Agent (Special Agency) Required?No

Initial Registration

Form:

Form CMS 116: Clinical Laboratory Improvement Amendments (CLIA) Application for Certification

Agency Fee:

Varies by type of laboratory and annual test volume.

Notes:

Applications should be submitted to the state agency which handles CLIA Certificate applications for the state in which your laboratory resides. See the list of CLIA State Agency Contacts for contact information.

Registration Renewal

Agency Fee:

Varies by type of laboratory and annual test volume.

Due:

Biennially

Notes:

There is no renewal application, simply submit the fee after receiving the invoice.

United States Clinical Laboratory Improvement Amendments (CLIA) Certificate of Compliance

Agency:United States Centers for Medicare & Medicaid Services (CMS) - Division of Clinical Laboratory Improvement & Quality
Law:

42 U.S.C. § 263a

Foreign Qualification is Prerequisite:No
Registered Agent (Special Agency) Required?No

Initial Registration

Form:

Form CMS 116: Clinical Laboratory Improvement Amendments (CLIA) Application for Certification

Agency Fee:

Varies by type of laboratory and annual test volume.

Notes:

Applications should be submitted to the state agency which handles CLIA Certificate applications for the state in which your laboratory resides. See the list of CLIA State Agency Contacts for contact information.

Registration Renewal

Agency Fee:

Varies by type of laboratory and annual test volume.

Due:

Biennially

Notes:

There is no renewal application, simply submit the fee after receiving the invoice.

United States Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver

Agency:United States Centers for Medicare & Medicaid Services (CMS) - Division of Clinical Laboratory Improvement & Quality
Law:

42 U.S.C. § 263a

Foreign Qualification is Prerequisite:No
Registered Agent (Special Agency) Required?No

Initial Registration

Form:

Form CMS 116: Clinical Laboratory Improvement Amendments (CLIA) Application for Certification

Agency Fee:

$180, invoiced after approval

Notes:

Applications should be submitted to the state agency which handles CLIA Certificate applications for the state in which your laboratory resides. See the list of CLIA State Agency Contacts for contact information.

Registration Renewal

Agency Fee:

$180

Due:

Biennially

Notes:

There is no renewal application, simply submit the fee after receiving the invoice.

Related Government Agencies

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