General Surgery Board Review Regulatory Frameworks & Compliance 2 — Questions and Answers
Question 1: Under the Emergency Medical Treatment and Labor Act (EMTALA), a hospital with a dedicated emergency department must provide a medical screening examination to:
- Any individual who comes to the emergency department and requests examination or treatment (Correct answer)
- Only patients with life-threatening conditions
- Patients who present with a valid insurance card
- Only patients referred by a primary care physician
Correct answer: Any individual who comes to the emergency department and requests examination or treatment
EMTALA requires hospitals with dedicated EDs to provide a medical screening exam to any individual who presents and requests evaluation, regardless of ability to pay.
Question 2: The Health Insurance Portability and Accountability Act (HIPAA) Security Rule specifically applies to:
- Electronic protected health information (ePHI) (Correct answer)
- Paper-based medical records only
- Verbal disclosures of patient information
- All forms of protected health information equally
Correct answer: Electronic protected health information (ePHI)
The HIPAA Security Rule applies specifically to electronic protected health information, while the Privacy Rule covers all forms of PHI.
Question 3: A surgeon wishes to perform a clinical trial involving a new surgical technique. Which federal agency must approve the Investigational New Drug or Device Exemption before proceeding?
- The Food and Drug Administration (FDA) (Correct answer)
- The Centers for Medicare & Medicaid Services (CMS)
- The Office for Human Research Protections (OHRP)
- The Joint Commission
Correct answer: The Food and Drug Administration (FDA)
The FDA regulates investigational drugs and devices; an IDE or IND application must be approved before clinical trials involving novel devices or drugs may begin.
Question 4: Which of the following best describes the role of a hospital's Institutional Review Board (IRB)?
- Protecting the rights and welfare of human research subjects (Correct answer)
- Credentialing and privileging surgical staff
- Auditing billing and coding compliance
- Reviewing adverse surgical outcomes for quality improvement
Correct answer: Protecting the rights and welfare of human research subjects
The IRB is federally mandated to review, approve, and oversee research involving human subjects to protect their rights, welfare, and safety.
Question 5: The Stark Law (Physician Self-Referral Law) prohibits a physician from referring Medicare patients to an entity for designated health services if the physician:
- Has a financial relationship with that entity, unless an exception applies (Correct answer)
- Has not obtained prior authorization from CMS
- Does not hold board certification in the relevant specialty
- Is employed by a different hospital system than the entity
Correct answer: Has a financial relationship with that entity, unless an exception applies
The Stark Law is a strict-liability statute prohibiting referrals to entities in which the physician has a financial interest, subject to specific statutory and regulatory exceptions.
Question 6: Under the National Practitioner Data Bank (NPDB) regulations, a hospital is required to query the NPDB when:
- Granting initial medical staff privileges and at each reappointment (Correct answer)
- A physician applies for a DEA controlled substance license
- A surgeon is named in a state medical board complaint
- A malpractice settlement exceeds $50,000
Correct answer: Granting initial medical staff privileges and at each reappointment
Hospitals must query the NPDB when granting initial privileges and at least every two years upon reappointment to identify adverse actions or malpractice history.
Question 7: Which federal law established the requirement for hospitals to inform patients of their right to execute an advance directive?
- The Patient Self-Determination Act (PSDA) of 1990 (Correct answer)
- The Emergency Medical Treatment and Labor Act (EMTALA)
- The Health Care Quality Improvement Act (HCQIA)
- The Affordable Care Act (ACA)
Correct answer: The Patient Self-Determination Act (PSDA) of 1990
The PSDA requires Medicare and Medicaid-participating providers to inform adult patients of their right to make healthcare decisions and execute advance directives.
General Surgery Board Review Regulatory Frameworks & Compliance 2
Under the Emergency Medical Treatment and Labor Act (EMTALA), a hospital with a dedicated emergency department must provide a medical screening examination to: