Which of the following organization is responsible for test categorization and CLIA studies

Clinical Laboratory Program

What you need for Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate

CLIA Certificates

The Clinical Laboratory Improvement Amendments (CLIA) establishes quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed.

Before a clinical laboratory can apply for state licensure to operate in Massachusetts, it must first obtain CLIA certification. The Centers for Medicare & Medicaid Services (CMS) issues 4 different CLIA certificates based on the type of testing performed by the laboratory:

• Certificate of Waiver: this certificate is issued to a laboratory to perform only waived tests.
• Certificate for Provider-Performed Microscopy Procedures (PPMP): this certificate is issued to a laboratory in which a physician, midlevel practitioner or dentist performs no tests other than the microscopy procedures. This certificate permits the laboratory to also perform waived tests.
• Certificate of Compliance: this certificate is issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements.
• Certificate of Accreditation: this is a certificate that is issued to a laboratory on the basis of the laboratory's accreditation by an accreditation organization approved by the Health Care Financing Administration (HCFA).

CMS may issue a Certificate of Registration to a laboratory to enable the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations.

Fees for Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate

Once DPH receives a complete CLIA application and Laboratory Test List, a fee remittance coupon will be issued that indicates the laboratory’s CLIA identification number, the certificate fee, and the compliance fee (if applicable). Please note that all fees should be submitted to CMS at the address indicated on the coupon.

CLIA fees are based on the certificate requested by the laboratory and, for moderate and high complexity laboratories, the annual volume and types of testing performed.

How to apply Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate

More info for Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate

While the CLIA program is managed by CMS, there are other federal agencies which oversee various components.

• CMS is charged with the implementation of CLIA, including laboratory registration, fee collection, surveys, surveyor guidelines and training, enforcement, approvals of PT providers, accrediting organizations, and exempt states.
• The Centers for Disease Control and Prevention (CDC) is responsible for the CLIA studies, convening the Clinical Laboratory Improvement Amendments Committee (CLIAC), and providing scientific and technical support/consultation to DHHS/CMS.
• The Food and Drug Administration (FDA) is responsible for test categorization.

CMS resources

Additional information about the CLIA requirements and programs is available on the CMS CLIA website. Information available through this site includes:

• CLIA regulations
• Interpretative guidelines relating to the regulations
• Text Complexity database
• Approved Proficiency Testing Programs list
• Certificate fee schedule

Contact for Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate