Quality Control / CLIA Regulations Flashcards
What is another word for quality assurance? Quality control?
Assurance - External evaluation
Control - Internal evaluation
How do you reduce total error in a device? (Reduce systematic bias or random bias?)
Reduce systematic bias (get nearer to the true value)
What is the Levy Jennings Chart? Why is it useful? What does a trend up or downward mean? Shifts?
It is a type of quality control chart and it is useful because you can see how accurate your device is over time.
Trend downward or upward = getting worse
Shift = caused by calibration errors
How often should QCs be run? What does the frequency depend on?
Evenly distributed in runs of patient samples for large number of samples
Frequency depends on:
- each assay run
- each calibration cycle
- each day
What are the components of overall quality systems?
- Personnel qualifications
- Process control
- Proficiency testing
- Calibration and validation
- Quality assurance and inspections
- Results reporting
- Sample collection, stability, and transportation
What if your device shows data outside of the acceptance limit?
- Document and corrective action
- Repeat measurements
Every lab needs to be inspected by which organization(s)?
CMS or state agency
What are the CLIA test complexities? Give examples for each.
Waived - Fecal occult blood test, pregnancy test, Hgb, blood glucose monitors
Moderate -MOST automated procedures
Complex - Radioimmunoassays, atomic absorption spectrophotometry, chromatography
What sanctions are enforced for non-compliance of CLIA?
- You can’t test certain analytes
- Screw yourself of Medicaid and Medicare payments
- Penalties from $50 to $1000/day
- You might lose yo license
- You can be treated as a criminal (jail tyyyyme)
