Introduction To Clinical Laboratory
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List 7 Lab Departments or Divisions | show 🗑
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Clinical Laboratory Sciences Professional Team | show 🗑
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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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show | Four levels of test complexity
Waived testing (doesn't require lab professional status to perform/interpret)
PPM - Provider (physician) performed microscopy
Moderately complex testing
Highly complex testing
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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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show | Occupational Safety and Health Administration
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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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Other OSHA Regulation | show 🗑
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HIPAA | show 🗑
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show | 1996 and Issued by Dept. of Health and Human Services (HHS)
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(OSHA Regulations) 3. Universal Precaution Workplace Practices must include:(7) | show 🗑
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(OSHA Regulations) 1. Universal Precautions | show 🗑
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show | gloves
lab coats
eye protection (mask or face shields)
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show | Medical Laboratory Technician (MLT)
Complete training in basic laboratory sciences
Entry-level education = an associate degree (AS)
Credientials = MLT
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MLS | show 🗑
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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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FDA Level 1 | show 🗑
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FDA Level 2 | show 🗑
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FDA Level 3 | show 🗑
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show | simple labs cleared for home used by FDA (pregnancy test)
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HIPPA | show 🗑
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Created by:
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