APHA APHA Legal, Ethical & Professional Standards in Immunization 2 — Questions and Answers
Question 1: Which immunization information system (IIS) / registry requirement supports the principle of 'reminder-recall' in immunization practice?
- IIS must be accessible only to billing departments
- IIS enables providers to identify patients due or overdue for vaccines and send reminders (Correct answer)
- IIS records are only accessible to the CDC at the federal level
- IIS data may not be shared across state lines under any circumstances
Correct answer: IIS enables providers to identify patients due or overdue for vaccines and send reminders
Immunization Information Systems enable reminder-recall programs by identifying patients who are due or overdue for vaccines and facilitating outreach to improve vaccination rates.
Question 2: The Emergency Use Authorization (EUA) pathway differs from full FDA approval in that vaccines under EUA:
- Are not subject to any safety monitoring after release
- May be authorized more quickly during a public health emergency, with ongoing safety surveillance required (Correct answer)
- Cannot be administered to any population under age 18
- Require 10 years of clinical trial data before authorization
Correct answer: May be authorized more quickly during a public health emergency, with ongoing safety surveillance required
EUA allows the FDA to authorize vaccines more rapidly during a declared public health emergency based on available evidence, while requiring continued safety surveillance and data collection.
Question 3: According to HIPAA, when may a patient's immunization records be disclosed to a school without a specific patient authorization?
- Never — schools are never permitted to access immunization records
- Only when directly requested by a school administrator in writing
- When state law requires or allows reporting of proof of immunization to schools (Correct answer)
- Only when the patient is under age 5
Correct answer: When state law requires or allows reporting of proof of immunization to schools
Under HIPAA, immunization records may be disclosed to schools without patient authorization when state law requires or permits schools to have proof of student immunization.
Question 4: Vaccine lot numbers must be recorded in immunization records primarily to facilitate:
- Insurance billing and reimbursement processing
- Vaccine recall identification and adverse event investigation traceability (Correct answer)
- Marketing research by pharmaceutical manufacturers
- Calculating provider administration fees
Correct answer: Vaccine recall identification and adverse event investigation traceability
Recording vaccine lot numbers enables rapid identification of affected patients during a vaccine recall or safety signal investigation, ensuring traceability for public health response.
Question 5: The Vaccines for Children (VFC) program is a federally-funded program that provides free vaccines to which population?
- All children under age 18 regardless of insurance status
- Eligible children who are uninsured, underinsured, Medicaid-enrolled, or American Indian/Alaska Native (Correct answer)
- Only children of federal government employees
- Children attending federally-funded Head Start programs exclusively
Correct answer: Eligible children who are uninsured, underinsured, Medicaid-enrolled, or American Indian/Alaska Native
The VFC program provides free vaccines to children who are Medicaid-enrolled, uninsured, underinsured (for vaccines not covered by insurance), or American Indian/Alaska Native.
Question 6: Which ethical principle is most directly upheld by ensuring equitable distribution of vaccines to underserved communities?
- Autonomy
- Nonmaleficence
- Justice (Correct answer)
- Beneficence
Correct answer: Justice
Justice requires fair and equitable distribution of benefits and burdens in healthcare, including ensuring that vaccines reach underserved and vulnerable communities without discrimination.
APHA APHA Legal, Ethical & Professional Standards in Immunization 2
Which immunization information system (IIS) / registry requirement supports the principle of 'reminder-recall' in immunization practice?