APHA Immunization Documentation & Reporting 1 — Questions and Answers
Question 1: What is the primary purpose of a Vaccine Information Statement (VIS)?
- To document the pharmacist's credentials for vaccine administration
- To inform patients about the benefits and risks of a vaccine before vaccination (Correct answer)
- To serve as the official billing record for immunization services
- To notify the state health department of vaccine inventory levels
Correct answer: To inform patients about the benefits and risks of a vaccine before vaccination
VIS documents are federally required to inform patients (or their guardians) about the benefits and risks of a vaccine prior to receiving it.
Question 2: Which federal law mandates that healthcare providers give patients a Vaccine Information Statement before administering certain vaccines?
- The Affordable Care Act (ACA)
- The Health Insurance Portability and Accountability Act (HIPAA)
- The National Childhood Vaccine Injury Act (NCVIA) of 1986 (Correct answer)
- The Federal Food, Drug, and Cosmetic Act (FDCA)
Correct answer: The National Childhood Vaccine Injury Act (NCVIA) of 1986
The National Childhood Vaccine Injury Act of 1986 requires providers to give patients or their guardians a VIS before administering vaccines covered under the Act.
Question 3: Which of the following pieces of information MUST be documented in a patient's vaccination record at the time of vaccine administration?
- The patient's insurance copay amount
- The vaccine lot number, manufacturer, and administration site (Correct answer)
- The patient's primary care physician's phone number
- The pharmacist's home address
Correct answer: The vaccine lot number, manufacturer, and administration site
Federal law requires documentation of the vaccine lot number, manufacturer, administration date, site, and route in the patient's permanent medical record.
Question 4: What is the primary purpose of the Vaccine Adverse Event Reporting System (VAERS)?
- To approve new vaccines before they reach the market
- To detect possible safety problems with licensed vaccines through post-market surveillance (Correct answer)
- To reimburse patients who experience vaccine reactions
- To track pharmacist immunization credentials nationally
Correct answer: To detect possible safety problems with licensed vaccines through post-market surveillance
VAERS is a national post-market safety surveillance system that detects possible signals of adverse events associated with US-licensed vaccines.
Question 5: Who jointly manages the Vaccine Adverse Event Reporting System (VAERS)?
- The FDA and the CDC (Correct answer)
- The APhA and the ACIP
- The CMS and the DEA
- The NIH and the WHO
Correct answer: The FDA and the CDC
VAERS is co-managed by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
Question 6: What is an Immunization Information System (IIS), also known as a vaccine registry?
- A federal database that tracks pharmacist DEA numbers
- A confidential, population-based computerized database that records all vaccine doses administered (Correct answer)
- A private insurance billing platform for immunization claims
- A system that tracks only pediatric vaccinations for school enrollment
Correct answer: A confidential, population-based computerized database that records all vaccine doses administered
An IIS is a confidential, population-based, computerized database that records all immunization doses administered by participating providers, enabling consolidated vaccination histories.
Question 7: When administering a vaccine, which edition of the Vaccine Information Statement should a pharmacist use?
- Any edition, as long as it covers the same vaccine
- The most current edition available, as determined by its publication date (Correct answer)
- The edition published in the year the patient was born
- The edition approved by the state board of pharmacy
Correct answer: The most current edition available, as determined by its publication date
Providers must use the most current VIS edition, identified by the publication date printed on the document, to ensure patients receive up-to-date information.
APHA Immunization Documentation & Reporting 1
What is the primary purpose of a Vaccine Information Statement (VIS)?