CLIA Regulatory Requirements & Documentation 5 — Questions and Answers
Question 1: Which of the following CLIA sanctions can be imposed on a laboratory found to have condition-level deficiencies?
- Verbal warning only
- Civil money penalty up to $10,000 per day per violation (Correct answer)
- Mandatory retraining for all staff
- Suspension of a single test only
Correct answer: Civil money penalty up to $10,000 per day per violation
CMS may impose civil money penalties of up to $10,000 per day for each condition-level deficiency identified under CLIA.
Question 2: What is the purpose of the CLIA certificate of registration?
- Permanent authorization to perform all laboratory tests
- Temporary authorization allowing a new laboratory to operate while awaiting inspection (Correct answer)
- Exemption from proficiency testing requirements
- Authorization to perform only waived tests
Correct answer: Temporary authorization allowing a new laboratory to operate while awaiting inspection
A Certificate of Registration is a temporary certificate that allows a new laboratory to operate while it undergoes its initial inspection to determine the appropriate certificate level.
Question 3: Under CLIA, which entity is authorized to act as a deemed accreditation organization (AO) in place of CMS inspections?
- State health departments only
- Approved private accrediting organizations such as CAP or The Joint Commission (Correct answer)
- FDA regional offices
- CDC laboratory improvement programs
Correct answer: Approved private accrediting organizations such as CAP or The Joint Commission
CMS-approved accrediting organizations such as CAP and The Joint Commission can survey laboratories in lieu of CMS inspections under CLIA's deemed status program.
Question 4: Which of the following test result documentation elements is explicitly required by CLIA regulations?
- Patient's insurance information
- Identity of the person who performed the test (Correct answer)
- Cost of the test
- Patient's consent signature
Correct answer: Identity of the person who performed the test
CLIA requires documentation of the identity of the person who performed each test as part of the patient test record.
Question 5: A laboratory discovers that it failed a proficiency testing event. Under CLIA, what is the required initial response?
- Immediately cease testing until the next PT event
- Perform an investigation and take corrective action, documenting the findings (Correct answer)
- Retest the original PT sample using a different method
- Report the failure to the FDA within 24 hours
Correct answer: Perform an investigation and take corrective action, documenting the findings
CLIA requires laboratories to investigate the cause of PT failure, implement corrective action, and document all findings — testing may continue during this process.
Question 6: Under CLIA, which personnel role is responsible for ensuring the day-to-day operations of a high-complexity laboratory comply with all CLIA requirements?
- Clinical consultant
- Technical supervisor
- General supervisor
- Laboratory director (Correct answer)
Correct answer: Laboratory director
The laboratory director bears overall responsibility for ensuring that all CLIA requirements are met, including day-to-day operations of the laboratory.
Question 7: How does CLIA define a 'test system' for the purposes of regulatory requirements?
- Only the analytical instrument used to perform a test
- The instructions, reagents, equipment, and procedures used to produce a test result (Correct answer)
- The laboratory information system (LIS) used to report results
- The proficiency testing program used for a specific analyte
Correct answer: The instructions, reagents, equipment, and procedures used to produce a test result
CLIA defines a test system as the instructions, reagents, equipment, and procedures used together to produce a result for a specific laboratory test.
CLIA Regulatory Requirements & Documentation 5
Which of the following CLIA sanctions can be imposed on a laboratory found to have condition-level deficiencies?