CLIA Clinical Laboratory Improvement Amendments Act Questions And Answers With Verified Solutions

CDC - Centers for Disease Control and Prevention Protect public health and safety Disease prevention Environmental health Occupational safety and health Prevention and education Chemical hygiene plan (CHP) - Procedures to be used when working with hazardous chemicals Control measures to reduce exposure to hazardous chemicals Measure to check that protective equipment is functioning properly Employee information and training programs CLIA - Of 1988, federal regulatory program that *sets the standards for the quality of laboratory testing* CMS - The Centers for Medicare and Medicaid Services Regulates all lab testing performed on humans COLA - Commission on Office Laboratory Accreditation Maintains quality laboratory operations and inspections Control log must show - Date and time of test Results expected Results obtained Action taken for correction, if anyInitials of person performing the test Records retained at least 2yrs Eye protection - Wearing eye protection and face shield when blood or body fluid exposure may occur is required by OSHA bloodborne pathogens standards FDA - Food and Drug Administration Protecting and promoting public health through the regulations and supervision of laboratory and blood transfusion products High complexity tests - Rare in medical office Includes: advanced cell studies (cytogenetic) Cytology (pap test) Histopathy Manual cell counts Laboratory procedure manual - Primary reference in operating the POL Procedures must follow manufacturers testing instructions Instructions in product insert Procedures require reagents and controls Laboratory safety - Common sense Safety focused attitude Good personal behavior Good housekeeping Moderate complexity tests - *It uses complex manual methodology or instrumentation* Performed by highly trained personnel inside clinical labRequires detailed quality assurance (QA) and QC procedures MSDS (material safety data sheet) - Product name and identification Hazardous components Health hazard data Fire and explosive data Spill and disposal procedures Recommendations for PPE Handling, storage, and transportation precaution