APHA Immunization Documentation & Reporting 2 — Questions and Answers
Question 1: According to federal requirements, when must a Vaccine Information Statement be provided to the patient or legal guardian?
- Within 24 hours after vaccine administration
- Before each dose of the vaccine is administered (Correct answer)
- Only at the first dose of a vaccine series
- Only when the patient specifically requests one
Correct answer: Before each dose of the vaccine is administered
Federal law requires that a VIS be given to patients or their legal representatives before EACH dose of a covered vaccine is administered.
Question 2: What is the CDC's v-safe program?
- A vaccine lot number tracking database for manufacturers
- A smartphone-based after-vaccination health checker using text messaging and web surveys (Correct answer)
- A voluntary adverse event compensation fund for patients
- A verification system confirming pharmacist immunization certification
Correct answer: A smartphone-based after-vaccination health checker using text messaging and web surveys
V-safe is a CDC smartphone-based tool that uses text messaging and online surveys to check in on patients' health after vaccination and encourages VAERS reporting when appropriate.
Question 3: Which of the following adverse events is healthcare providers required to report to VAERS?
- Mild injection-site redness lasting less than 24 hours
- A patient's complaint of feeling anxious before the injection
- Events listed in the VAERS Table of Reportable Events Following Vaccination (Correct answer)
- Any patient who declines a second dose of a vaccine series
Correct answer: Events listed in the VAERS Table of Reportable Events Following Vaccination
Healthcare providers are required to report adverse events listed in the VAERS Table of Reportable Events Following Vaccination; all other adverse events may be reported voluntarily.
Question 4: Which of the following data elements must a pharmacist record when documenting VIS distribution?
- The patient's insurance plan name and group number
- The publication date of the VIS and the date it was given to the patient (Correct answer)
- The pharmacist's personal National Provider Identifier (NPI)
- The wholesale acquisition cost of the vaccine
Correct answer: The publication date of the VIS and the date it was given to the patient
Providers must document the publication date of the VIS given and the date it was provided to the patient or legal representative as part of the vaccination record.
Question 5: Which of the following best describes the role of Immunization Information Systems (IIS) in supporting vaccination programs?
- They replace the need for pharmacists to keep their own patient vaccination records
- They consolidate vaccination records from multiple providers to generate reminder/recall notices and assess coverage (Correct answer)
- They are used exclusively by state health departments and cannot be accessed by pharmacists
- They only track vaccines administered by physicians in clinical settings
Correct answer: They consolidate vaccination records from multiple providers to generate reminder/recall notices and assess coverage
IIS consolidate records from multiple providers, enabling reminder/recall notifications, identification of under-vaccinated populations, and assessment of vaccination coverage rates.
Question 6: Who may submit a report to VAERS?
- Only licensed physicians and nurse practitioners
- Only state and federal public health officials
- Anyone, including healthcare providers, patients, parents, and caregivers (Correct answer)
- Only the vaccine manufacturer after receiving a complaint
Correct answer: Anyone, including healthcare providers, patients, parents, and caregivers
VAERS accepts reports from anyone, including healthcare providers (who are mandated for certain events), patients, parents, caregivers, and even vaccine manufacturers.
Question 7: What is the standard timeframe within which a healthcare provider should submit a VAERS report for a serious adverse event following vaccination?
- Within 24 hours of the adverse event
- As soon as possible, ideally within 30 days of the adverse event (Correct answer)
- Within 7 business days, no exceptions
- Only at the end of each calendar year in an annual summary report
Correct answer: As soon as possible, ideally within 30 days of the adverse event
Reports should be submitted to VAERS as soon as possible, ideally within 30 days of the adverse event, though there is no strict cutoff to prevent late reporting.
APHA Immunization Documentation & Reporting 2
According to federal requirements, when must a Vaccine Information Statement be provided to the patient or legal guardian?