APHA Quality Assurance & Compliance 2 — Questions and Answers
Question 1: Which organization publishes the Vaccine Information Statements (VIS) that pharmacists must provide before immunization?
- CDC (Correct answer)
- FDA
- ACIP
- APhA
Correct answer: CDC
The CDC produces and updates Vaccine Information Statements as required by the National Childhood Vaccine Injury Act.
Question 2: A pharmacist discovers a vial of influenza vaccine stored at 10°C instead of the required 2–8°C range. What is the FIRST action?
- Quarantine the vial and do not use it (Correct answer)
- Administer the vaccine since it is still cool
- Return the vial to the manufacturer immediately
- Document the error and continue using the vial
Correct answer: Quarantine the vial and do not use it
Vaccines exposed to out-of-range temperatures must be quarantined immediately pending evaluation, as efficacy may be compromised.
Question 3: Under NCVIA, which vaccines REQUIRE a current VIS to be given to the patient or guardian before administration?
- All vaccines covered by the National Vaccine Injury Compensation Program (Correct answer)
- Only childhood vaccines under the VFC program
- Any vaccine ordered by a physician
- Vaccines given in hospital settings only
Correct answer: All vaccines covered by the National Vaccine Injury Compensation Program
Federal law mandates VIS distribution for all vaccines covered by the National Vaccine Injury Compensation Program regardless of setting.
Question 4: What is the purpose of the Vaccine Adverse Event Reporting System (VAERS)?
- To detect potential safety signals after vaccine administration (Correct answer)
- To certify vaccines as safe before market release
- To track vaccine inventory at pharmacies
- To schedule patient vaccination appointments
Correct answer: To detect potential safety signals after vaccine administration
VAERS is a passive surveillance system that collects adverse event reports to identify possible vaccine safety signals.
Question 5: When should a pharmacist complete a VAERS report?
- After any adverse event following vaccination, especially serious events (Correct answer)
- Only when the patient files a formal complaint
- Only for events listed on the vaccine package insert
- Only if a physician requests the report
Correct answer: After any adverse event following vaccination, especially serious events
VAERS encourages reporting of any clinically significant adverse event after vaccination, particularly serious or unexpected events.
Question 6: A pharmacist administers a vaccine and must record it in the patient's record. Which information is NOT required by federal law for the immunization record?
- Patient's insurance billing code (Correct answer)
- Date of administration
- Vaccine manufacturer and lot number
- Administering pharmacist's name
Correct answer: Patient's insurance billing code
Federal law requires the date, vaccine name, manufacturer, lot number, and provider name but not the billing code in the immunization record.
Question 7: Which quality indicator best reflects that a pharmacy immunization program is maintaining cold chain integrity?
- Temperature logs showing consistent 2–8°C storage with no excursions (Correct answer)
- High patient satisfaction survey scores
- Low number of vaccine refusals by patients
- Rapid checkout times at the pharmacy counter
Correct answer: Temperature logs showing consistent 2–8°C storage with no excursions
Continuous temperature logs within the recommended range are the primary indicator of successful cold chain maintenance.
APHA Quality Assurance & Compliance 2
Which organization publishes the Vaccine Information Statements (VIS) that pharmacists must provide before immunization?