CLIA Certificate Types & Test Complexity Classifications Flashcards
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Read the first 7 CLIA Certificate Types & Test Complexity Classifications flashcards as text
If a Certificate of Waiver laboratory begins performing non-waived tests without obtaining the appropriate certificate, what is the regulatory consequence?
Answer: The lab may face civil monetary penalties and must cease non-waived testing immediately
Performing non-waived testing under a Certificate of Waiver is a CLIA violation that can result in civil monetary penalties, suspension, limitation, or revocation of the certificate.
Which federal agency is primarily responsible for implementing and enforcing CLIA regulations?
Answer: Centers for Medicare & Medicaid Services (CMS)
CMS has primary authority for implementing CLIA, issuing certificates, conducting inspections, and enforcing compliance, though FDA categorizes tests and CDC provides scientific support.
For a test to qualify for FDA waiver categorization, manufacturers must demonstrate that the risk of an erroneous result is:
Answer: Negligible and poses no unreasonable risk of harm if performed incorrectly by a layperson
FDA grants waiver status when a test is so simple and accurate that the risk of harm from an erroneous result is negligible even when performed by untrained users following the manufacturer's instructions.
To which entity is a CLIA certificate issued?
Answer: Each specific laboratory location (site)
CLIA certificates are issued to individual laboratory sites; each physical location performing testing must hold its own separate CLIA certificate.
Which statement best describes a 'high-complexity' test under CLIA?
Answer: A test that scores 13 or higher on the 7-criterion scoring system
Under CLIA, tests scoring 13 or higher on the 7-criterion system are classified as high complexity, requiring the most stringent personnel qualifications and quality standards.
Under CLIA, which of the following activities does the Certificate of Waiver NOT exempt a laboratory from complying with?
Answer: Manufacturer's instructions for performing the test
Even Certificate of Waiver laboratories must follow the manufacturer's test instructions; failure to do so constitutes a CLIA violation regardless of the certificate type.
Provider-Performed Microscopy (PPM) procedures are classified under which complexity level?
Answer: Moderate complexity
PPM procedures are classified as moderate-complexity tests but are exempt from most moderate-complexity requirements because they are personally performed by the treating provider during the patient encounter.