organizations responsible test categorization clia studies moderate-complexity tests require:

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

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality. Learn more about CLIA.

Laboratories are on the frontline for protecting our communities’ health. CDC provides clinical and public health laboratories with training and technical assistance to help them achieve the highest-quality laboratory science while ensuring the safety of laboratory professionals and the communities where they work. Learn more about CDC’s laboratory quality efforts.

Clinical Laboratory Program

The Details of Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate

the Contents of the Apply for a Clinical Laboratory Improvement Amendment (CLIA) Certificate page

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

To apply for enrollment in the CLIA program, a laboratory must complete the following documents:

  • CLIA Application for Certification (PDF) (Please note that the CLIA identification number should be left blank as this will be assigned when the application form is processed)
  • Laboratory Tests Performed On-Site List (PDF) | (RTF)
  • Find out more information about the acceptable forms of documentation (DOCX) for qualifications of moderate and high complexity laboratory personnel

Please email the completed application materials to .

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

  • Subscribe to the DPH Clinical Laboratory Listserv 
  • Clinical Laboratory Program laws, regulations, and circular letters 

Which of the following organizations is responsible for the standards of laboratory procedures?

Review questions workbook.

Which government agency is responsible for determining the CLIA complexity of all laboratory tests?

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests.

What is the purpose of CLIA quizlet?

What is the purpose of CLIA '88? to safeguard the public by regulating all testing of specimens taken from the human body.

What are the three categories of testing under CLIA quizlet?

CLIA'88 regulations require that three different procedures be performed in the quality-control protocol for automated hematology instruments. The procedures are calibration, control sampling testing, and proficiency testing.

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