Regulatory Standards & Ethics Flashcards

Which federal law established the Clinical Laboratory Improvement Amendments (CLIA) to regulate laboratory testing?

Answer: CLIA of 1988

CLIA of 1988 established federal standards for all laboratory testing performed on human specimens to ensure accuracy and reliability.

A medical technician discovers a coworker falsifying patient test results. What is the MOST appropriate ethical action?

Answer: Report it to a supervisor or compliance officer immediately

Falsifying patient results is fraud and endangers patient safety, requiring immediate reporting through proper channels.

Under CLIA, which category requires the LEAST complex testing procedures with minimal risk of error?

Answer: Waived tests

Waived tests are the simplest category under CLIA, cleared by the FDA for home use and posing minimal risk of harm if performed incorrectly.

What does the principle of 'beneficence' require of medical technicians?

Answer: To act in the best interest of the patient

Beneficence requires healthcare workers to actively promote patient well-being and act in their best interest.

Which agency is responsible for enforcing OSHA standards in clinical and laboratory settings?

Answer: Department of Labor

OSHA operates under the U.S. Department of Labor and is responsible for enforcing workplace safety standards including those in healthcare settings.

A patient revokes consent for a procedure mid-way through. What must the medical technician do?

Answer: Pause and honor the patient's revocation of consent

Patients have the right to withdraw consent at any time, and the technician must stop and honor this decision.

Which standard specifies safe handling and disposal of biohazardous waste in the medical laboratory?

Answer: OSHA Bloodborne Pathogens Standard

The OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) requires proper handling, labeling, and disposal of biohazardous materials.