CMT Regulatory Standards & Ethics 2 — Questions and Answers
Question 1: Which federal law established the Clinical Laboratory Improvement Amendments (CLIA) to regulate laboratory testing?
- HIPAA of 1996
- CLIA of 1988 (Correct answer)
- OSHA Act of 1970
- ADA of 1990
Correct answer: CLIA of 1988
CLIA of 1988 established federal standards for all laboratory testing performed on human specimens to ensure accuracy and reliability.
Question 2: A medical technician discovers a coworker falsifying patient test results. What is the MOST appropriate ethical action?
- Ignore it to avoid workplace conflict
- Report it to a supervisor or compliance officer immediately (Correct answer)
- Confront the coworker directly and threaten to report them
- Wait to see if the coworker corrects the behavior
Correct 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.
Question 3: Under CLIA, which category requires the LEAST complex testing procedures with minimal risk of error?
- Moderate complexity
- High complexity
- Waived tests (Correct answer)
- Provider-performed microscopy
Correct 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.
Question 4: What does the principle of 'beneficence' require of medical technicians?
- To avoid causing harm to patients
- To act in the best interest of the patient (Correct answer)
- To respect patient autonomy
- To treat all patients equally
Correct 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.
Question 5: Which agency is responsible for enforcing OSHA standards in clinical and laboratory settings?
- FDA
- CDC
- Department of Labor (Correct answer)
- CMS
Correct 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.
Question 6: A patient revokes consent for a procedure mid-way through. What must the medical technician do?
- Continue because the procedure was already started
- Pause and honor the patient's revocation of consent (Correct answer)
- Ask a supervisor to convince the patient to continue
- Document the refusal and proceed anyway
Correct 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.
Question 7: Which standard specifies safe handling and disposal of biohazardous waste in the medical laboratory?
- HIPAA Privacy Rule
- OSHA Bloodborne Pathogens Standard (Correct answer)
- CLIA Proficiency Testing Rule
- FDA 510(k) Clearance
Correct answer: OSHA Bloodborne Pathogens Standard
The OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) requires proper handling, labeling, and disposal of biohazardous materials.
CMT Regulatory Standards & Ethics 2
Which federal law established the Clinical Laboratory Improvement Amendments (CLIA) to regulate laboratory testing?