Question

Define the following terms:

CLIA and its role in clinical laboratory oversite-

CMS and its role in clinical laboratory oversite-

FDA and its role in clinical laboratory oversite-

CDC and its role in clinical laboratory oversite-

Answer 1

1. The Clinical Laboratory Improvement Amendments of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.The objective of the CLIAprogram is to ensure quality laboratory testing. ... Although all clinicallaboratories must be properly certified to receive Medicare or Medicaid payments, CLIAhas no direct Medicare or Medicaid program responsibilities.In general terms, the CLIAregulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.The Clinical Laboratory Improvement Amendment, CLIA 88, requires every clinical laboratory in the US to document the education and continuing education of each of its employees. ... CLIA 88 also establishes what tests phlebotomists are permitted to perform.The section of the federal regulations titled “Standards and Certification: Laboratory Requirements” is issued by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA law passed by Congress (see below). In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.
2. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).The objective of the CLIA program is to ensure quality laboratory testing.
3. The Food and Drug Administration (FDA) is a government agency established in 1906 with the passage of the Federal Food and Drugs Act.The FDA's services include inspecting food and food-processing facilities to ensure wholesomeness and safety; scrutinizing food and drugs for pets and farm animals; ensuring that cosmetics will not cause harm; monitoring the health of the nation's blood supply; ensuring that medicines, medical devices, and biologicals (such as insulinand vaccines) are safe and effective; and testing radiation-emitting products such as microwave ovens to protect the public. The FDA also oversees health and safety labeling of these products. All new prescription and over-the-counter drugs are subject to FDA approval. The FDA must determine that a new drug produces the benefits it's supposed to produce, without causing side effects that would outweigh the benefits. It does so by looking at the results of clinical trials done outside the FDA. When serious adverse effects from a medication are reported, the FDA has the power to force the manufacturer to make changes in the drug, change its safety labeling or marketing practices, or remove the medication from the market.
4. The Centers for Disease Control and Prevention is a national public health institute in the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgia.As the nation's health protectionagency, CDC saves lives and protects people from health threats. To accomplish our mission, CDC conducts critical science and provides health information that protects our nation against expensive and dangerous health threats, and responds when these arise.The CDC works with partnersat the local, state and national level to monitor and prevent disease outbreaks (including bioterrorism), implement disease prevention strategies and maintain national health statistics. The agency also leads public health efforts to prevent and control infectious and chronic diseases, injuries, workplace hazards, disabilities and environmental health threats. The CDC focuses on the following five strategic areas: increasing support to local and state health departments, improving global health, decreasing leading causes of death, strengthening surveillance and epidemiology, and reforming health policies.The CDC's disease prevention efforts include educating the public on how to recognize and avoid contracting common infectious diseases, such as the flu and strep throat. The CDC also monitors outbreaks of chronic diseases, including Ebola, which are often met with updates from the CDC on how to recognize and combat possible symptoms.For people who believe they might have contracted an infectious disease,the CDC website shares guidance on how to test for the disease and avoid spreading it to others before they can receive treatment.More in-depth directions for treatment, including possible quarantine, are available for patients and healthcare workers that may have been exposed to more potent viruses, such as Zika.