CLIA Compliance and Lab Safety Exam Questions With Verified Answers.

CLIA Compliance and Lab Safety Exam Questions With Verified Answers. Clinical Laboratory Improvement Amendments (CLIA) - answerguidelines established by Congress in 1988 to standardize and improve laboratory testing; a federal regulatory program that sets standards for the quality of lab testing Commission on Office Laboratory Accreditation (COLA) - answerworks to support the health care industry by providing knowledge and resources for maintaining quality laboratory operations Laws Governing the Clinical Lab - answer-CMS regulates all lab testing performed on humans through CLIA -may be state regulations for lab testing -state requirements may be stricter than federal-- follow state requirements then Levels of testing - answerCLIA established three levels of testing based on complexity of method: 1. Waived test 2. Moderate-complexity test 3. High-complexity test Waived tests - answer-Simple, one-step tests -performing them incorrectly can cause errors and endanger patient health -government requires a Certificate of Waiver (CW) -oversight controlled by HHS Waived tests include: -urine dipstick or reagent tablets -fecal occult blood packets -urine pregnancy testing kits using color comparison charts -centrifuged microhematocrits -point-of-care blood glucose determinatino testing **Even with the waiver, the POL must still follow all manufacturers' recommendations for each piece of equipment or product used for testing. Department of Health and Human Services (HHS) - answerUS government's agency for protecting the health of all Americans and providing essential human services Centers for Disease Control and Prevention (CDC) - answerUS federal agency under HHS that works to protect public health and safety; CDC provides information to enhance health decisions. CDCs job is to focus national attention on: -disease prevention -environmental health -occupational safety and health -prevention and education activities to improve the health of the people of the US Food and Drug Administration (FDA) - answerresponsible for protecting and promoting public health through the regulation and supervision of blood transfusions, medical devices, and other medically and nonmedically related products; an agency of HHS They have NOT provided waived status for every lab test. Moderate-complexity tests - answerOne or more of these characteristics: -uses complex manual methodologies or instrumentation -is suitable for use only by highly trained scientists inside the clinical lab -requires detailed QA and QC procedures Tests include: -urine and throat cultures -automated testing for cholesterol, high-density lipoproteins, and triglycerides -gram staining -microscopic urinalysis