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11 Cards in this Set
- Front
- Back
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What is the purpose of CLIA '88 |
It covers proficiency testing, patient testing, QA, QC, requirements, inspections, and consultations |
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3 main categories of complexity |
1. Waived-simple and safe 2. Moderate-manuel procedures, little risk 3. High- Multiple complex steps, higher risk |
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Provider-Performed Microscopy |
Allows doctors to look under a microscope without a MLT or MT license |
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Centralized Laboratory |
stationary, in hospitals |
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Point of Care testing |
POCT testing at patients bedside |
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Reference labs |
Samples are sent here for observations |
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Physician Office Laboratories |
POL outpatients |
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8 non-analytical factors |
1. Qualified Personnel 2. Est. Lab Policies 3. Lab procedure manuel 4. Proper procedures for collecting and storing sample 5. Preventative maintenence equipment 6. Appropriate methodology 7. Est. QC and QA techniques 8. Accuracy in reporting results |
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Quality Control & Quality Assessment |
QC- over the testing procedure QA- over everything from collection, testing, and reporting |
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Define: Pre-analytical factors Analytical factors Post analytical factors |
Pre-analytical: sample collection Analytical: QC, testing Post analytical: Reporting |
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What are calibrators vs. Controls |
Calibrators are used to standardize the instrument, controls are used to check sample accuracy |
