Cmia Research Paper

Developed in 1988, CLIA consist of regulations set in place by the federal government to improve the quality of laboratory testing. Under CLIA laboratories have to be certified by their state and CMS (Center for Medicare and Medicaid Services) before they can accept any human samples to test. Laboratories may have multiple certifications for multiple types of testing. CLIA has waived some test that has been determined to be simple, easy, and has a low-risk of erroneous test results. These waived tests are performed in doctors’ offices instead of sent off to an outside lab because they are less expensive to run. Most tests are run on specimen that are easily obtained from the body, such as blood, urine, feces, and discharge from various body parts. Physician’s office laboratories must apply for a certificate of waiver from the Center for Medicare and Medicaid Services. …show more content…
All three agencies play a different but very important role. The FDA categorizes test based on complexity, review requests for waivers, and develops rules/guidance. Collecting fees, issuing certificates, conducting inspections, and approving accreditation are all the CMSs jobs. They also, perform state exemptions, monitor laboratories on the Proficiency Test, and publish the rules and regulations of CLIA. CDCs role is to provide analysis, research, and technical assistance to laboratories’, develop standards and practice guidelines for certain test including cytology. Monitoring PT practices, improving studies, developing and distributing the information and education on changes are all things the CDC handles; they even manage the advisory committee