CVP Regulatory and Ethical Considerations 2

Question 1

Which federal agency has primary authority over medical devices used in cardiopulmonary bypass, including oxygenators and heart-lung machines?

Accepted Answer

Food and Drug Administration (FDA)

Answer

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?

Accepted Answer

Report the incident through the institution's established chain of command or incident reporting system

Answer

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:

Accepted Answer

Treatment, payment, or healthcare operations require it

Answer

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:

Accepted Answer

Ensure practitioners remain current with evolving clinical standards and technology

Answer

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:

Accepted Answer

Discuss perioperative DNR management with the surgeon and anesthesiologist before the case and document the agreed plan

Answer

Best practice requires pre-procedure discussion of DNR status and perioperative suspension or modification, documented with multidisciplinary agreement before the operation begins.

(CVP) Cardiovascular Perfusionist Practice Test

(CVP) Cardiovascular Perfusionist Practice Test

CVP Regulatory and Ethical Considerations 2