CLIA Safety & Risk Management in Clinical Labs 4 — Questions and Answers
Question 1: A clinical laboratory using Category II exempt test systems under CLIA still has which ongoing obligation?
- Enrolling in proficiency testing for all waived tests
- Following the manufacturer's instructions for test performance (Correct answer)
- Hiring a laboratory director with MD credentials
- Submitting monthly QC reports to CMS
Correct answer: Following the manufacturer's instructions for test performance
Even for waived tests, CLIA requires laboratories to follow manufacturers' instructions to ensure accurate and reliable results.
Question 2: When disposing of sharps in a clinical laboratory, which container specification is required by OSHA's Bloodborne Pathogen Standard?
- Any rigid container with a lid labeled 'sharps'
- Closable, puncture-resistant, leak-proof, and labeled with the biohazard symbol (Correct answer)
- A red bag with a twist-tie closure
- A cardboard box lined with a plastic bag
Correct answer: Closable, puncture-resistant, leak-proof, and labeled with the biohazard symbol
OSHA specifies that sharps containers must be closable, puncture-resistant, leak-proof on sides and bottom, and labeled with the biohazard symbol or color-coded red.
Question 3: A laboratory's exposure control plan must be reviewed and updated at minimum:
- Every 5 years
- Annually and whenever new tasks or procedures affect occupational exposure (Correct answer)
- Only when an actual exposure incident occurs
- Every 3 years per OSHA mandate
Correct answer: Annually and whenever new tasks or procedures affect occupational exposure
OSHA's Bloodborne Pathogen Standard requires the exposure control plan to be reviewed and updated at least annually and whenever procedures change.
Question 4: In CLIA quality systems, which term describes the process of comparing a laboratory's test results with those of peer laboratories using the same methodology?
- Internal quality control
- Proficiency testing (PT) / external quality assessment (Correct answer)
- Calibration verification
- Westgard rule monitoring
Correct answer: Proficiency testing (PT) / external quality assessment
Proficiency testing or external quality assessment involves submitting samples to an approved PT provider and comparing results with peer laboratories using the same method.
Question 5: A laboratory worker develops a contact dermatitis rash after repeated glove use. The MOST appropriate first step to address this occupational safety concern is:
- Discontinue all glove use to allow skin healing
- Evaluate for latex allergy and consider alternative glove materials (Correct answer)
- Apply topical steroid cream and continue normal glove use
- File a CLIA complaint with CMS immediately
Correct answer: Evaluate for latex allergy and consider alternative glove materials
The appropriate response to suspected latex sensitivity is to evaluate for true latex allergy and provide alternative non-latex gloves to maintain both protection and worker safety.
Question 6: Under CLIA, which entity has primary responsibility for ensuring the laboratory's testing personnel are competent to perform their assigned duties?
- The Joint Commission (TJC)
- The laboratory director (Correct answer)
- CMS regional surveyors
- The state health department
Correct answer: The laboratory director
CLIA regulations place primary responsibility for ensuring personnel competency on the laboratory director, who must implement and oversee competency assessment programs.
Question 7: A laboratory identifies that centrifuge O-rings have degraded, creating a potential aerosol exposure risk for infectious samples. This situation should be categorized as which type of hazard?
- Chemical hazard requiring SDS review
- Biological hazard requiring engineering control correction (Correct answer)
- Ergonomic hazard requiring workstation redesign
- Radiation hazard requiring dosimetry monitoring
Correct answer: Biological hazard requiring engineering control correction
Degraded centrifuge seals creating aerosols from infectious specimens represent a biological hazard requiring immediate engineering control — repair or replacement before continued use.
CLIA Safety & Risk Management in Clinical Labs 4
A clinical laboratory using Category II exempt test systems under CLIA still has which ongoing obligation?