80/20 Flashcards
What is the main focus of Quality Assurance (QA)?
Preventing errors by ensuring consistent, standardized lab processes.
What is the main focus of Quality Control (QC)?
Detecting and correcting errors in test results using control samples.
Example of a QA activity?
SOPs
Example of a QC activity?
Running controls with each patient batch to verify accuracy.
What does CLIA stand for?
Clinical Laboratory Improvement Amendments.
Who enforces CLIA regulations?
CMS (Centers for Medicare & Medicaid Services).
What does CAP provide for laboratories?
Accreditation and high-standard inspections (not enforcement).
What does OSHA regulate in labs?
Workplace safety for lab personnel.
What does HIPAA protect?
Patient privacy and health data confidentiality.
What is the purpose of LIS in a lab?
Manages, stores, and tracks patient results and lab data securely.
How does LIS improve patient safety?
Reduces data entry errors and controls access to patient info.
What are common biosafety measures in the lab?
PPE, BSCs (Biological Safety Cabinets), proper waste disposal, and decontamination procedures.
Pathogens handled in BSL-2?
Moderate-risk pathogens like Salmonella, Hepatitis B.
What’s unique about BSL-3 labs?
Negative air pressure, respirators, airborne pathogen containment.
What does Lean aim to eliminate?
Waste in lab processes (unnecessary steps, delays, errors).
What does Six Sigma aim to reduce?
Variability in testing to achieve near-perfect results.
What is root cause analysis used for?
Finding the underlying reason for lab errors to prevent recurrence.
Why are SOPs important in QA?
Ensure all lab staff follow consistent and correct procedures.
What’s a common HIPAA violation?
Talking about patient results with unauthorized staff.
Why is continuing education important in lab work?
Keeps staff updated on current methods and regulations.
