CLIA Safety & Risk Management in Clinical Labs 2 — Questions and Answers
Question 1: Under OSHA's Bloodborne Pathogen Standard, which of the following is required when engineering controls alone cannot eliminate exposure risk?
- Terminate the task immediately
- Use appropriate personal protective equipment (PPE) (Correct answer)
- File an incident report before proceeding
- Obtain supervisor approval before continuing
Correct answer: Use appropriate personal protective equipment (PPE)
OSHA requires PPE as a secondary control measure when engineering controls cannot fully eliminate bloodborne pathogen exposure risk.
Question 2: A clinical laboratory receives a chemical shipment without a Safety Data Sheet (SDS). What is the MOST appropriate immediate action?
- Use the chemical with extra caution until the SDS arrives
- Return the shipment and request an SDS before use (Correct answer)
- Download a generic SDS from the internet as a substitute
- Treat the chemical as non-hazardous until classified
Correct answer: Return the shipment and request an SDS before use
OSHA's Hazard Communication Standard requires an SDS before using any hazardous chemical; the shipment should not be used until proper documentation is provided.
Question 3: Which CLIA requirement specifically addresses the prevention of specimen mix-ups in the pre-analytical phase?
- Daily calibration verification
- Patient specimen identification and integrity requirements (Correct answer)
- Proficiency testing enrollment
- Personnel competency assessment schedules
Correct answer: Patient specimen identification and integrity requirements
CLIA mandates that laboratories establish and follow procedures for proper patient identification and specimen integrity to prevent pre-analytical errors.
Question 4: In a clinical lab, an autoclave used for decontamination of biohazardous waste must be tested for efficacy using:
- Chemical indicator strips placed inside every load
- Biological indicators containing Geobacillus stearothermophilus spores (Correct answer)
- Temperature-sensitive tape on the exterior of bags
- A monthly visual inspection of the chamber
Correct answer: Biological indicators containing Geobacillus stearothermophilus spores
Biological indicators using Geobacillus stearothermophilus spores are the gold standard for verifying autoclave sterilization efficacy.
Question 5: A laboratory technician accidentally ingests a small amount of an unknown chemical. After calling Poison Control, which document should be consulted for additional medical information to provide to emergency responders?
- The laboratory's quality manual
- The chemical's Safety Data Sheet (SDS), Section 4 (Correct answer)
- The personnel competency file
- The CLIA certificate of compliance
Correct answer: The chemical's Safety Data Sheet (SDS), Section 4
SDS Section 4 (First Aid Measures) provides specific emergency treatment guidance for chemical exposures and ingestion.
Question 6: Which of the following best describes a 'near miss' in the context of laboratory risk management?
- An error that reached the patient and caused harm
- An unplanned event that did not result in harm but had the potential to do so (Correct answer)
- A proficiency testing failure reported to CMS
- A calibration drift detected during daily QC
Correct answer: An unplanned event that did not result in harm but had the potential to do so
A near miss is an unplanned event with potential for harm that did not actually result in patient injury, and it should be documented and analyzed to prevent future incidents.
Question 7: When a laboratory employee is exposed to a bloodborne pathogen via needlestick, which timeline applies for the initial HIV post-exposure prophylaxis (PEP) to be most effective?
- Within 72 hours of exposure (Correct answer)
- Within 1 week of exposure
- Within 24 hours of exposure only
- PEP is equally effective regardless of time
Correct answer: Within 72 hours of exposure
CDC guidelines recommend initiating HIV PEP as soon as possible and ideally within 72 hours of exposure for maximum effectiveness.
CLIA Safety & Risk Management in Clinical Labs 2
Under OSHA's Bloodborne Pathogen Standard, which of the following is required when engineering controls alone cannot eliminate exposure risk?