CLIA Safety & Risk Management in Clinical Labs 3

Question 1

A CLIA-certified laboratory must perform a risk assessment when implementing a new test system. Which element is MOST critical to include in this assessment?

Accepted Answer

Identification of failure modes and their potential impact on patient safety

Answer

The cost per reportable result

Answer

The vendor's marketing materials

Answer

Staff preferences for the new instrument

Question 2

Under CLIA regulations, what is the minimum frequency required for calibration verification of a quantitative test?

Accepted Answer

Every 6 months or when specific triggering events occur

Answer

Every 30 days

Answer

Daily before patient testing

Answer

Only when purchasing a new reagent lot

Question 3

A laboratory fire involving a compressed gas cylinder requires which specific action BEFORE evacuation?

Accepted Answer

Close the cylinder valve if safely accessible and evacuate

Answer

Attempt to extinguish the fire with a CO2 extinguisher aimed at the cylinder

Answer

Cool the cylinder with water from a safe distance before leaving

Answer

Leave the cylinder and pull the nearest fire alarm

Question 4

Which CLIA-mandated document describes the step-by-step procedures a laboratory uses to perform each test, including specimen requirements and reference ranges?

Accepted Answer

The procedure manual

Answer

The laboratory's CLIA certificate application

Answer

The quality assessment plan

Answer

The personnel qualification file

Question 5

During a power outage, a laboratory's backup generator fails. Which specimen type is at GREATEST immediate risk of preanalytical degradation?

Accepted Answer

Refrigerated blood samples awaiting CBC analysis

Answer

Dried blood spot cards stored at room temperature

Answer

Formalin-fixed tissue blocks in storage

Answer

Archived serum samples frozen at -80°C

Question 6

The 'Swiss Cheese Model' of accident causation is used in laboratory risk management to illustrate that:

Accepted Answer

Accidents occur when multiple layers of defense each have gaps that align

Answer

A single safeguard is sufficient to prevent all errors

Answer

QC failures always indicate instrument malfunction

Answer

Laboratory errors are random and unpredictable events

Question 7

A laboratory's chemical hygiene plan must specifically address which of the following for particularly hazardous substances (PHS)?

Accepted Answer

Designated areas, containment devices, decontamination procedures, and disposal

Answer

Employee health insurance requirements

Answer

Annual salary reviews for lab staff handling PHS

Answer

Marketing restrictions on PHS-based test results