CPI Infection Control & Prevention 3 — Questions and Answers
Question 1: A Certified Physician Investigator is reviewing a protocol involving bronchoscopy procedures. Which transmission-based precaution is most appropriate during this aerosol-generating procedure?
- Contact Precautions
- Droplet Precautions
- Airborne Precautions (Correct answer)
- Standard Precautions alone
Correct answer: Airborne Precautions
Bronchoscopy is an aerosol-generating procedure requiring Airborne Precautions, including N95 respirator use and negative-pressure room when feasible.
Question 2: Which regulatory body in the US sets standards for occupational exposure to blood-borne pathogens in research settings?
- FDA
- CDC
- OSHA (Correct answer)
- NIH
Correct answer: OSHA
OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) mandates employer protections for workers with occupational exposure to blood-borne pathogens.
Question 3: A trial site is conducting a study involving participants with active pulmonary tuberculosis. Staff entering participant rooms should wear at minimum a:
- Standard surgical mask
- N95 filtering facepiece respirator (Correct answer)
- Powered air-purifying respirator (PAPR)
- Face shield alone
Correct answer: N95 filtering facepiece respirator
An N95 respirator is the minimum respiratory protection required for entering rooms of patients with suspected or confirmed pulmonary TB.
Question 4: Which of the following disinfection methods achieves the HIGHEST level of disinfection short of sterilization?
- Low-level disinfection with quaternary ammonium compounds
- Intermediate-level disinfection with isopropyl alcohol
- High-level disinfection with glutaraldehyde (Correct answer)
- Cleaning with detergent and water
Correct answer: High-level disinfection with glutaraldehyde
High-level disinfection with glutaraldehyde or other high-level disinfectants destroys all microorganisms except high numbers of bacterial spores.
Question 5: An investigator conducting a vaccine trial must report a cluster of injection-site abscesses in participants. This is BEST classified as a:
- Protocol deviation
- Serious adverse event requiring expedited reporting (Correct answer)
- Site infection control failure requiring OSHA notification
- Minor adverse event documentable in routine reports
Correct answer: Serious adverse event requiring expedited reporting
A cluster of injection-site abscesses is a serious adverse event potentially linked to the investigational product or technique and requires expedited reporting.
Question 6: In a multi-site clinical trial, one site reports an unusually high rate of surgical site infections (SSIs). The FIRST step in investigation should be:
- Suspend enrollment at the site
- Conduct a root cause analysis of aseptic technique and processes (Correct answer)
- Report the site to the FDA
- Increase antibiotic prophylaxis doses
Correct answer: Conduct a root cause analysis of aseptic technique and processes
Root cause analysis of procedural technique, sterility practices, and environmental factors is the first step to identify and correct the source of excess SSIs.
Question 7: Which type of clinical trial participant population requires the MOST stringent infection prevention measures due to impaired host defenses?
- Elderly participants over 65
- Pediatric participants under 2
- Hematopoietic stem cell transplant recipients (Correct answer)
- Participants with controlled hypertension
Correct answer: Hematopoietic stem cell transplant recipients
Hematopoietic stem cell transplant recipients have profoundly impaired immunity and are at extreme risk for opportunistic infections, requiring the strictest protective measures.
CPI Infection Control & Prevention 3
A Certified Physician Investigator is reviewing a protocol involving bronchoscopy procedures.
Which transmission-based precaution is most appropriate during this aerosol-generating procedure?