Quiz #1 Flashcards
Origin of Laboratory Medicine:
-Hippocrates advocated a diagnostic protocol that included tasting the patient’s urine
20th century laboratory medicine highlights:
- Microbiology
- Clinical Chemistry
- Transfusion Medicine
CLIA:
- Clinical Laboratory Improvement Amendments: regulated testing by Centers for Medicare & Medicaid Services (CMS); CMS responsible for financial backing
- Passed in 1988 to ensure quality lab testing
- Carried out by CCSQ
- Waived and Non-Waived tests
Waived and Non-Waived tests:
- Categorization of in vitro diagnostic tests under CLIA; FDA responsible
- Based on potential for risk to public health
Waived Tests:
- Cleared for home use
- Low risk
Non-Waived Tests:
-Uses scoring system (scale of 1-3) based on 7 criteria
College of American Pathologists:
- Leader in lab quality assurance
- Inspects and accredits over 7600 labs globally
All work-related fatalities, amputations, inpatient hospitalizations, and all losses of an eye must be reported to OSHA within:
- Fatalities: 8 hours
- Everything else: 24 hours
HIPPA:
Health Insurance Portability and Accountability Act:
- Title I: protects insurance coverage
- Title II: Administrative Simplification
Anatomic Pathology:
- Focuses on the diagnosis of disease
- Histology, Cytology, Forensic Pathology
Clinical Pathology:
- Diagnosis based on lab analysis of bodily fluids, such as blood and urine
- Clinical Chemistry, Hematology, Blood Bank, Microbiology
American Society for Clinical Pathology (ASCP):
-Provides certification for pathologists and lab professionals
Reference/Normal Range:
- Found by testing thousands of samples from individuals without disease and on no medications
- 2 standard deviations in middle or represents 95% of results
Desirable Range:
- Groups of experts compare lab test results with clinical outcome and create new desirable or prognosis-related ranges
- ie: Cholesterol reference range
Therapeutic Range:
- Determined by the drug’s effect rather than its concentration in the blood
- ie: Target blood level for a medication
Critical Lab Value:
- Test that requires rapid clinical attention
- Prompt verbal notification must be given to member of healthcare team responsible for patient
Precision:
-Ability to repeatedly obtain results that are close to each other on the same sample
Accuracy:
-Relationship between the number obtained and the true result
False Positive:
-Lab suggests there is a disease but patient does not
False Negative:
-Lab suggests there is not a disease when there is not
Sensitivity:
- True positive rate
- Ability of a test to correctly identify individuals who have a given disease or condition
Specificity:
- True negative rate
- Ability of a test to correctly exclude individuals who do not have a given disease or condition
Prevalence:
-The number of existing cases in a population