Regulatory Issues
CLIA Certificates
- Laboratories subject to the Clinical Laboratory Improvement Amendments certification provisions must obtain and maintain a certificate based on the type and complexity of testing conducted.
CLIA Certificate Types
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Certificate of Registration
This certificate is issued to a laboratory that applies for a certificate of compliance or accreditation. A registration certificate enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined through on-site survey or verification of accreditation that all applicable requirements are met. This certificate permits the laboratory to also perform waived tests. A registration certificate is temporary and indicates only that the laboratory is registered with the Centers for Medicare and Medicaid Services and does not indicate approval or compliance with CLIA regulations. A registration certificate is valid until a survey takes place, or for two years, whichever is shorter. Registration certificates are not renewable, but can be reissued if the Centers for Medicare and Medicaid Services has determined compliance prior to the expiration date. -
Certificate of Waiver
This certificate is issued to a laboratory that performs only waived tests. -
Certificate of Provider Performed Microscopy Procedures
This certificate is issued to a laboratory in which a physician (MD or DO), podiatrist (DPM), midlevel practitioner (nurse practitioner (ARNP), nurse midwife, physician's assistant (PA) or Naturopath) or dentist personally performs one or more tests designated as waived tests and no others. -
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. This certificate permits the laboratory to perform moderate and/or high complexity testing depending on the laboratory personnel qualifications and compliance with all other applicable CLIA requirements, and to also perform waived tests. -
Certificate of Accreditation
This certificate is issued to a laboratory on the basis of the laboratory's accreditation by an accreditation organization approved by the Centers for Medicare and Medicaid Services. This certificate permits the laboratory to perform moderate and/or high complexity testing depending on the laboratory personnel qualifications and compliance with all other applicable CLIA and organizational requirements, and to also perform waived tests.