CVP Regulatory and Ethical Considerations 2 — Questions and Answers
Question 1: Which federal agency has primary authority over medical devices used in cardiopulmonary bypass, including oxygenators and heart-lung machines?
- Centers for Medicare & Medicaid Services (CMS)
- Food and Drug Administration (FDA) (Correct answer)
- Occupational Safety and Health Administration (OSHA)
- Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
Correct answer: Food and Drug Administration (FDA)
The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act, including all cardiopulmonary bypass equipment such as oxygenators, blood pumps, and tubing.
Question 2: A perfusionist discovers that a colleague falsified priming volume records after a case. What is the most appropriate initial action?
- Confront the colleague privately and ask them to self-report
- Ignore the incident if the patient had a good outcome
- Report the incident through the institution's established chain of command or incident reporting system (Correct answer)
- Discuss the issue with the patient's family directly
Correct answer: Report the incident through the institution's established chain of command or incident reporting system
Perfusionists have an ethical and professional duty to report falsified records through proper institutional channels to ensure patient safety and professional integrity.
Question 3: Under the Health Insurance Portability and Accountability Act (HIPAA), a perfusionist may share protected health information (PHI) with another provider without explicit patient authorization when:
- The patient is not present to object
- Treatment, payment, or healthcare operations require it (Correct answer)
- A family member requests it
- The information is more than 30 days old
Correct answer: Treatment, payment, or healthcare operations require it
HIPAA's Treatment, Payment, and Operations (TPO) provision permits sharing PHI among providers involved in coordinating or managing care without separate authorization.
Question 4: The American Board of Cardiovascular Perfusion (ABCP) requires certified perfusionists to complete continuing education to maintain certification primarily to:
- Generate revenue for the certifying board
- Ensure practitioners remain current with evolving clinical standards and technology (Correct answer)
- Satisfy insurance billing requirements
- Meet OSHA blood-borne pathogen training mandates
Correct answer: Ensure practitioners remain current with evolving clinical standards and technology
Continuing education requirements are designed to ensure that certified perfusionists maintain competency as techniques, technology, and evidence-based practices evolve.
Question 5: When a patient has a valid Do Not Resuscitate (DNR) order and requires cardiac surgery, the most appropriate approach for the perfusion team is to:
- Automatically suspend the DNR during surgery without discussion
- Discuss perioperative DNR management with the surgeon and anesthesiologist before the case and document the agreed plan (Correct answer)
- Refuse to participate in the case
- Contact the ethics committee during the procedure if cardiac arrest occurs
Correct answer: Discuss perioperative DNR management with the surgeon and anesthesiologist before the case and document the agreed plan
Best practice requires pre-procedure discussion of DNR status and perioperative suspension or modification, documented with multidisciplinary agreement before the operation begins.
Question 6: Which of the following best describes the perfusionist's legal liability exposure under the doctrine of respondeat superior?
- Perfusionists are personally liable for all adverse outcomes regardless of employer direction
- The employing institution may share liability for negligent acts performed by the perfusionist within the scope of employment (Correct answer)
- Only the cardiac surgeon bears liability for perfusion-related complications
- Federal law exempts hospital employees from personal malpractice claims
Correct answer: The employing institution may share liability for negligent acts performed by the perfusionist within the scope of employment
Under respondeat superior, an employer can be held vicariously liable for an employee's negligent acts committed within the scope of their employment, though the employee may also face personal liability.
Question 7: A perfusionist is asked by the surgeon to reuse a single-use oxygenator to reduce costs. The correct response is to:
- Comply if the device appears undamaged after inspection
- Refuse, because reuse of single-use devices violates FDA regulations and exposes patients to infection and device failure risk (Correct answer)
- Agree only if the device is sterilized with ethylene oxide
- Defer the decision to the hospital administrator
Correct answer: Refuse, because reuse of single-use devices violates FDA regulations and exposes patients to infection and device failure risk
The FDA prohibits reuse of single-use devices (SUDs) unless processed by an FDA-registered third-party reprocessor, and oxygenators are not approved for in-house reuse due to sterility and integrity concerns.
CVP Regulatory and Ethical Considerations 2
Which federal agency has primary authority over medical devices used in cardiopulmonary bypass, including oxygenators and heart-lung machines?