CLIA Safety & Risk Management in Clinical Labs 4

Question 1

A clinical laboratory using Category II exempt test systems under CLIA still has which ongoing obligation?

Accepted Answer

Following the manufacturer's instructions for test performance

Answer

Enrolling in proficiency testing for all waived tests

Answer

Hiring a laboratory director with MD credentials

Answer

Submitting monthly QC reports to CMS

Question 2

When disposing of sharps in a clinical laboratory, which container specification is required by OSHA's Bloodborne Pathogen Standard?

Accepted Answer

Closable, puncture-resistant, leak-proof, and labeled with the biohazard symbol

Answer

Any rigid container with a lid labeled 'sharps'

Answer

A red bag with a twist-tie closure

Answer

A cardboard box lined with a plastic bag

Question 3

A laboratory's exposure control plan must be reviewed and updated at minimum:

Accepted Answer

Annually and whenever new tasks or procedures affect occupational exposure

Answer

Every 5 years

Answer

Only when an actual exposure incident occurs

Answer

Every 3 years per OSHA mandate

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?

Accepted Answer

Proficiency testing (PT) / external quality assessment

Answer

Internal quality control

Answer

Calibration verification

Answer

Westgard rule monitoring

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:

Accepted Answer

Evaluate for latex allergy and consider alternative glove materials

Answer

Discontinue all glove use to allow skin healing

Answer

Apply topical steroid cream and continue normal glove use

Answer

File a CLIA complaint with CMS immediately

Question 6

Under CLIA, which entity has primary responsibility for ensuring the laboratory's testing personnel are competent to perform their assigned duties?

Accepted Answer

The laboratory director

Answer

The Joint Commission (TJC)

Answer

CMS regional surveyors

Answer

The state health department

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?

Accepted Answer

Biological hazard requiring engineering control correction

Answer

Chemical hazard requiring SDS review

Answer

Ergonomic hazard requiring workstation redesign

Answer

Radiation hazard requiring dosimetry monitoring