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Introduction To Clinical Laboratory

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show Lab Departments or Divisions Hematology Hemostasis (Coagulation) Urinalysis Clinical Chemistry (Biochemistry) Blood Bank (Immunohematology, Transfusion Services) Immunology and Serology Molecular Diagnostics Microbiology  
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show Clinical Laboratory Sciences Professional Team Medical laboratory scientists (MLS) Medical laboratory technicians (MLT) Phlebotomists Medical laboratory aides  
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Federal Regulatory Standards for Laboratories   show
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show CAP-certifies proficiency of clinical laboratories FDA-Rates the laboratory Testing OSHA-safety and inspections TJC-The joint Commission (every 2 yrs)  
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CLIA   show
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Two ways to get CLIA Certified   show
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Four Levels of test Complexity   show
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show Risk of harm to the patient Risk of erroneous result Level of personnel training Level of test complexity Knowledge and amount of interpretation required to evaluate test results Availability of test for home use  
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CLIA/FDA 3 Levels of Complexity   show
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CLIA Regulation Requirement   show
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OSHA   show
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show 1.Universal Precautions-treat all to be infectious 2.PPE(personnel protective equipment) 3.Universal Precaution Workplace Practices 4.HBV Vaccination Program-for all personnel 5.Annual Inspections  
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show Other OSHA Lab Regulations 1.Occupational Exposures to Hazardous Chemicals – chemical hygiene plan (CHP) must be put in place 2.Occupational Exposure to Formaldehyde 3.Prevention of the Transmission of Mycobacterium tuberculosis  
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show Health Insurance Portability and Accountability Act  
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HIPAA established in ____ and issued by _____   show
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show 1.handwashing 2.no recapping of contaminated needles 3.disposable of sharp objects in sharp containers 4.no food and drink in laboratory 5.no mouth pipetting 6.biohazard and appropriate warning labels and biosafety bags 7.dress code for safety  
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show lab personnel must treat all body fluid specimens as if they were infectious  
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show gloves lab coats eye protection (mask or face shields)  
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MLT   show
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show Must be educated in the basic sciences (biology, chemistry, physics, etc.), management, and education Complete training in basic laboratory sciences and special testing Entry-level education = BS Formerly CLS or Medical Technologist MT  
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show CAP  
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show FDA  
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Regulatory Agencies that oversea the safety inspection (schedule or unschedule) (safety regulations)   show
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show TJC  
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LAW that ensure privacy regulation   show
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NATIONAL ACCREDITING AGENCY FOR CLS (laboratory education program accreditation)   show
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TJC is surveyed inspection every   show
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show Clinical Laboratory Improvement Amendments  
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show 3-5 challenge 3 times per year  
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show labs must score 80 % or higher bloodbank must score 100%  
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Who monitors proficiency testing (pt)>   show
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show PPM Preferred Provider Microscopy  
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show Moderately complex testing  
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FDA Level 3   show
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Waived Level 1(FDA)   show
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HIPPA   show
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