Quality Assurance & Compliance Flashcards
7 cards from real APHA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Assurance & Compliance flashcards as text
Which organization publishes the Vaccine Information Statements (VIS) that pharmacists must provide before immunization?
Answer: CDC
The CDC produces and updates Vaccine Information Statements as required by the National Childhood Vaccine Injury Act.
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?
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.
Under NCVIA, which vaccines REQUIRE a current VIS to be given to the patient or guardian before administration?
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.
What is the purpose of the Vaccine Adverse Event Reporting System (VAERS)?
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.
When should a pharmacist complete a VAERS report?
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.
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?
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.
Which quality indicator best reflects that a pharmacy immunization program is maintaining cold chain integrity?
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.