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Question 1
What federal law regulates all laboratory testing performed on humans in the United States to ensure accuracy and reliability of results?
Answer: The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulate all human laboratory testing to ensure quality and accuracy of results.
Question 2
Which accrediting organization sets standards for hospital laboratories and conducts unannounced inspections to ensure compliance?
Answer: The College of American Pathologists (CAP) accredits hospital laboratories through unannounced inspections and peer-review programs.
Question 3
Under CLIA, which category of testing includes waived tests that pose the least risk of harm if performed incorrectly?
Answer: CLIA waived tests are the simplest, lowest-risk category and include tests like urine dipsticks and blood glucose monitoring cleared for home use.
Question 4
What is the primary role of OSHA in a phlebotomy setting?
Answer: OSHA sets and enforces workplace safety standards to protect healthcare workers from occupational hazards such as bloodborne pathogen exposure.
Question 5
Which federal regulation requires laboratories to report certain communicable diseases to public health authorities?
Answer: Mandatory reporting laws, enforced at the state level and guided by CDC guidelines, require labs to report specific notifiable diseases to protect public health.