Regulatory Standards and Ethics 1 Flashcards

Under HIPAA, a covered entity may disclose a patient's protected health information (PHI) without written authorization for which of the following purposes?

Answer: Public health activities authorized by law, such as disease surveillance

HIPAA permits disclosure of PHI without patient authorization for specific public interest purposes, including public health activities (e.g., reporting communicable diseases to health departments) as outlined under 45 CFR §164.512. The other options require explicit patient authorization.

The bioethical principle of 'non-maleficence' obligates a medical technician to:

Answer: Avoid performing actions that cause unnecessary harm or injury to the patient

Non-maleficence means 'do no harm.' It requires healthcare workers to weigh the risks of any intervention and refrain from actions whose potential harms outweigh their benefits. It is distinct from beneficence (acting for the patient's good), autonomy, and justice.

Which federal agency has primary regulatory authority over in vitro diagnostic devices and reagents used in medical laboratory testing?

Answer: Food and Drug Administration (FDA)

The FDA regulates medical devices, including in vitro diagnostic (IVD) devices and reagents, under the Federal Food, Drug, and Cosmetic Act. The CDC provides guidance, OSHA governs workplace safety, and CMS administers CLIA certification — but device approval falls under the FDA.

A medical technician discovers that a colleague has been documenting specimen collection times that were never actually performed. The most appropriate initial action is to:

Answer: Report the observation to a supervisor or through the facility's established chain of command

Healthcare ethics and most facility policies require staff to report suspected fraud, falsification, or misconduct through proper internal channels (supervisor, compliance officer, or ethics hotline). Ignoring misconduct violates professional standards; direct confrontation or contacting the patient bypasses established protocol.

State-designated mandatory reporting laws in healthcare primarily require providers to report:

Answer: Communicable diseases and conditions specified on the state's reportable disease list

Every U.S. state maintains a list of reportable communicable diseases (e.g., tuberculosis, hepatitis, STIs) that healthcare providers are legally required to report to public health authorities. Reporting is triggered by the specific diagnosis, not simply by an abnormal result, refusal of care, or insurance status.

A medical technician's 'scope of practice' is most authoritatively defined by:

Answer: State statutes, administrative regulations, and the standards set by the relevant certification body

Scope of practice is legally established through state law and administrative regulations, and further delineated by credentialing and certification organizations. While facility policies and physician direction operate within that framework, they cannot legally expand beyond what state law and certification standards permit.