QUALITY MANAGEMENT

• Quality


  Important to customers, can be assessed and monitored, can be improved, benefits exceed cost
• Quality-related factors


  • Customer satisfaction
  • Performance
  • Service
  • Pricing
  • Marketing
  • Customer feedback
  • Quality support
  • Customer complaint
• Quality assurance


  Planned and systematic activities to provide adequate confidence that requirements for quality will be met
• Quality assurance


  • Measurement of the broader dimension of quality from the perspective of the end-user (client)
  • Allows the lab to verify that its results are consistent with those of other labs using the same or similar methods of an analyte, and to confirm it is using a method correctly
• Why quality assurance of testing is important


  • Public expects high quality
  • Defines parameters & quality goals
  • Provides evaluation & improvement system
  • Assures reliability & comparability of results
  • Cost effective
  • Even the simplest of testing is not foolproof
• Quality assurance model


  • Staffing/personnel
  • Quality control (QC)
  • Proficiency testing (PT) also known as External quality assurance (EQA)
• Three phases of the testing process

  1. Pre-Analytic

  2. Analytic

  3. Post-Analytic
• Quality control


  Systematic monitoring of analytic processes to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results
• Quality control


  A testing designed to assess the "HEALTH" of an analytical method
• Quality control


  • Error detection
  • Error prevention
  • Measure performance (Bias, Imprecision, Total Error)
  • Monitor performance
  • Validate performance
• QC results in lab


  Used to validate (confirm) whether the instrument is operating within pre-defined specifications, concluding that patient test results are reliable
• Once the system is validated


  Patient results can be used for diagnosis, prognosis or treatment
• Calibration


  Setting the analyzer to give correct results, uses calibrators (standards)
• Quality control


  Checking if the analyzer is producing correct results, monitoring the instrument's calibration and other analytical processes
• Precision


  The consistency of a series of test results, the closeness of agreement between independent test results obtained under prescribed conditions, the degree of replication of data, the ability of an analytical method to give repeated results on the same sample that agree with one another
• Accuracy


  How close a test value is to the actual/target/true value
• Reliability


  The capacity of a method to maintain both accuracy and precision, the capacity to produce the same results on one sample again and again when performed by the same individual using the same lot numbers on the same instruments, the capacity of the method to produce the same results on one sample again and again when performed by different individuals on different days using different sets of reagents
• Sensitivity


  Ability of an analytical method to measure the smallest concentration of the analyte of interest
• Specificity


  Ability of an analytical method to measure only the analyte of interest
• Diagnostic sensitivity


  Ability of the test to detect the proportion of individuals with that disease who test positively with the test
• Diagnostic specificity


  Ability of the test to detect the proportion of individuals without the disease who test negatively for the disease
• Proficiency testing or external quality assessment


  Central organization sends out challenge specimens for testing, laboratories' results are evaluated
• External quality assurance


  • Early warning-system for problems
  • Measure of laboratory quality
  • Valuable benchmarking tool (standardization and traceability)
  • Indicator of where to direct improvement efforts
  • Monitor of changes in technology and testing practices (evaluation component)
• Method evaluation


  1. Select testing method

  2. Develop method

  3. Establish test method