CPI Infection Control & Prevention 2 — Questions and Answers
Question 1: In a clinical trial, a participant develops a catheter-associated urinary tract infection (CAUTI). Which organism is most commonly implicated in CAUTIs?
- Staphylococcus aureus
- Escherichia coli (Correct answer)
- Pseudomonas aeruginosa
- Candida albicans
Correct answer: Escherichia coli
E. coli is the most common causative pathogen in catheter-associated urinary tract infections.
Question 2: A researcher notices that trial staff are not consistently performing hand hygiene between participant contacts. The MOST effective immediate intervention is:
- Send a memo reminding staff of policy
- Install alcohol-based hand rub dispensers at point-of-care (Correct answer)
- Suspend the trial pending retraining
- Report the breach to the IRB immediately
Correct answer: Install alcohol-based hand rub dispensers at point-of-care
Point-of-care placement of alcohol-based hand rub dispensers is the most effective environmental intervention to improve hand hygiene compliance.
Question 3: Which of the following blood-borne pathogens has the highest transmission risk after a needlestick injury from an infected source?
- HIV
- Hepatitis C virus (HCV)
- Hepatitis B virus (HBV) (Correct answer)
- Cytomegalovirus (CMV)
Correct answer: Hepatitis B virus (HBV)
HBV has the highest transmission risk per needlestick (~30%), compared to ~3% for HCV and ~0.3% for HIV.
Question 4: A clinical trial site receives a shipment of investigational vaccines requiring storage at 2–8°C. Upon arrival, the refrigerator temperature log shows an excursion to 12°C overnight. The PI should FIRST:
- Discard the vaccines immediately
- Quarantine the vaccines and contact the sponsor (Correct answer)
- Administer the vaccines as the excursion was brief
- Report the excursion to the FDA
Correct answer: Quarantine the vaccines and contact the sponsor
Vaccines affected by a temperature excursion must be quarantined and the sponsor contacted to assess viability before any use or disposal.
Question 5: Standard Precautions in a clinical research setting apply to:
- Only participants known to have communicable diseases
- All blood and body fluids regardless of diagnosis (Correct answer)
- Participants on Contact Precautions only
- Immunocompromised participants exclusively
Correct answer: All blood and body fluids regardless of diagnosis
Standard Precautions assume all blood and body fluids are potentially infectious and apply to every participant regardless of known infection status.
Question 6: In the context of clinical research, which action BEST reduces the risk of cross-contamination between investigational product preparations?
- Wearing a lab coat during preparation
- Using dedicated preparation areas and cleaning between uses (Correct answer)
- Labeling each preparation clearly
- Preparing all products at the same time
Correct answer: Using dedicated preparation areas and cleaning between uses
Dedicated preparation areas with cleaning between uses physically prevent cross-contamination of investigational products.
Question 7: A participant in an oncology trial develops febrile neutropenia. Which infection control measure is MOST critical to implement immediately?
- Contact Precautions
- Droplet Precautions
- Protective (Reverse) Isolation (Correct answer)
- Airborne Precautions
Correct answer: Protective (Reverse) Isolation
Protective (reverse) isolation protects severely immunocompromised patients from environmental pathogens that would not harm immunocompetent individuals.
CPI Infection Control & Prevention 2
In a clinical trial, a participant develops a catheter-associated urinary tract infection (CAUTI).
Which organism is most commonly implicated in CAUTIs?