Quality Management

• What is the main focus of quality management?

  Processes and their improvement to satisfy customer needs
• How is quality management defined by CLSI and ISO?

  As coordinated activities to direct and control an organization regarding quality
• What are the four main components of quality management?

  Quality planning, quality assurance, quality control, and quality improvement
• What does quality management focus on besides product or service quality?

  Means to achieve quality
• How does quality management achieve more consistent quality?

  By using quality assurance and control of processes as well as products
• What is quality assurance?

  An overall management plan to guarantee the integrity of data
• What does quality control involve?

  A series of analytical measurements to assess the quality of analytical data
• What does quality assurance encompass?

  A systemic laboratory program including preanalytical, analytical, and postanalytical factors
• What does quality assurance monitor?

  Excessive variation in specimen acceptability, test methodologies, instruments, reagents, quality control, and personnel competencies
• What are the three phases of quality assurance?

  1. Pre-analytical Phase: Patient ID, specimen storage, mixing of the sample
  2. Analytical Phase: Focus on quality control; analysis of the sample
  3. Post-Analytical Phase: Transcription of patient data and laboratory results
• What is the purpose of quality control?

  To ensure precision and accuracy in the laboratory
• What are the objectives of quality control?

  To check the stability of the machine, quality of reagents, and technical errors
• What does sensitivity refer to in quality control?

  The ability of a method to detect and measure even the smallest amount of a substance
• How is sensitivity expressed?

  As a percentage
• What is analytical sensitivity?

  The ability to measure minute concentrations of the analyte
• What is diagnostic sensitivity?

  The ability of the test to detect a proportion of individuals with the disease
• Why is diagnostic sensitivity important in screening tests?

  To detect true positives and minimize false negatives
• What is the formula for diagnostic sensitivity?

  [Diagnostic Sensitivity (%)]
• What does specificity refer to in quality control?

  The ability of a method to measure only the desired component without interference
• What is analytical specificity?

  The ability to measure only one unknown substance
• What is diagnostic specificity?

  The ability of the test to detect a proportion of individuals without the disease
• Why is diagnostic specificity important in confirmatory tests?

  To detect true negatives and minimize false positives
• What are the definitions of positive and negative predictive value?

  • Positive Predictive Value: Probability that subjects with a positive screening test truly have the disease
  • Negative Predictive Value: Probability that subjects with a negative screening test truly don’t have the disease
• What does accuracy refer to in quality control?

  The ability of a method to determine the exact value of the substance of interest
• What is precision or reproducibility in quality control?

  The ability of a method to give repeated results on the same sample that agree with one another
• What does practicality refer to in quality control?

  The degree by which a method is easily repeated
• What does reliability refer to in analytical methods?

  The ability to maintain accuracy and precision over time
• What are the kinds of quality control?

  • Intralab Quality Control (Internal): Establish reference values, daily monitoring of accuracy and precision
  • Interlab Quality Control (External): Proficiency testing, unknown specimens from reference laboratories
• What is a standard solution used for?

  For accuracy in measurements
• What is a control solution used for?

  To achieve precision in measurements
• What is a blank solution?

  A solution without the specimen used to set the reading to zero
• What are the two kinds of quality control reagents?

  • Commercially Prepared: Manufactured by companies, can be lyophilized or non-lyophilized
  • Non-Commercially Prepared: Sources include left-over sera (pooled serum)