Quality Assessment, Lab Design, and Workflow

• What is the definition of quality in laboratory management?

  Doing the right things right the first time
• What does quality control rely on?

  Quantitative statistical methods focusing on the final product
• What is described as "the tools" in quality management?

  Quality Control
• What is the foundation of quality control?

  Descriptive analysis or descriptive statistics
• How is quality assurance defined in healthcare institutions?

  By the success of the total organization
• What is the overall management plan in quality assurance aimed at?

  Guaranteeing the integrity of the data
• What should every laboratory strive to ensure quality services?

  • Obtain modern equipment
  • Hire well-trained staff
  • Ensure a safe physical environment
  • Create a good management team
• What does Quality Systems Management promote?

  That things can always be done better
• What are the key components of Total Quality Management (TQM)?

  • Focus on teams and processes
  • Reduce errors through employee empowerment
  • Support constant patient satisfaction
  • Continuous improvement of organization processes
• What is the goal of Continuous Quality Improvement (CQI)?

  To continually improve practices beyond standards
• What does Six Sigma describe?

  Variability in defects per unit
• What does a higher sigma value indicate?

  Fewer defects in a process
• What is the main focus of Lean methodology?

  To reduce waste in laboratory activities
• Who is referred to as the Evangelist of quality management?

  Philip Crosby
• What is one of Philip Crosby's key principles?

  Quality is free, poor quality is expensive
• Who is credited with providing concepts for the TQM model?

  1. Edwards Deming
• What cycle did Walter Shewhart originate?

  PDCA (Plan-do-check-act) cycle
• What does the PDCA cycle aim to achieve?

  Continual improvement from problem-based to problem-solved
• Who is known as the Father of Quality?

  Joseph Juran
• What is the Pareto Principle also known as?

  80/20 rule
• What does Pareto Analysis help identify?

  Factors accounting for the greatest effects
• Who is recognized as a Quality Control expert in laboratories?

  Dr. James Westgard
• What does accuracy refer to in quality control statistics?

  Closeness of a result to the actual value
• What does precision refer to in quality control statistics?

  Ability to reproduce a value consistently
• What is a Gaussian Curve used for in quality control?

  Distribution of errors from analytical methods
• What does CUSUM calculate?

  Difference between QC results and target means
• What is the purpose of the Youden/Twin Plot?

  To compare results from different laboratories
• What is the most commonly used quality control chart?

  Shewhart Levey-Jennings Chart
• What do Westgard Control Rules indicate?

  If analytical processes are out of control
• What are the Westgard Multirule System rules?

  • 12s rule: Warning when control limits exceed mean ± 2s
  • 13S rule: Reject when a single control exceeds mean ± 3s
  • 22s rule: Reject when 2 consecutive controls exceed mean ± 2s
  • R4s rule: Reject when 1 control exceeds mean ± 2s in a group
  • 41S rule: Reject when 4 consecutive controls exceed mean ± 1s
  • 10x rule: Reject when 10 consecutive controls fall on one side of the mean
• What does the mean measure in quality control statistics?

  Systematic error or accuracy
• What does standard deviation measure?

  Precision or dispersion of values around the mean
• What does the coefficient of variation allow?

  Comparison of precision and variability of methods
• What is a random error?

  Error occurring by chance at any time
• What is a systematic error?

  Error influencing observations consistently in one direction
• What is a trend in quality control?

  Control values increasing or decreasing for six days
• What is a shift in quality control?

  Control values on one side of the mean for six days
• What are the three phases of the testing process in laboratory workflow?

  • Pre-analysis: Activities before testing
  • Analysis: Laboratory activities producing results
  • Post-analysis: Patient reporting and result interpretation
• What can cause signing the wrong calibrator values?

  Improperly prepared or deteriorating reagents
• What maintenance error can affect pipettors?

  Not adjusted correctly or misaligned