QUALITY MANAGEMENT SYSTEM Flashcards
Most widely used approach to quality improvement in healthcare.
PDCA cycle
Management philosophy and process aimed at improving quality in all aspects of work.
Total Quality Management (TQM)
Framework component necessary to standardize remedies, establish performance measures, and ensure quality requirements are satisfied.
Quality Planning (QP)
Framework component defining processes, policies, practices, and procedures for all work aspects.
Quality Laboratory Processes (QLP)
Statistical control procedures and non-statistical checks like linearity checks and temperature monitors.
Quality Control (QC)
Broad measures of laboratory performance including TAT, patient identification, and specimen collection.
Quality Assurance (QA)
Structured problem-solving process for identifying root causes and remedies for problems.
Quality Improvement (QI)
Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.
Six Sigma
Indicators of Six Sigma performance improvement.
Improved performance, quality, bottom line, customer, and employee satisfaction
Five steps of Six Sigma (DMAIC).
Define, Measure, Analyze, Improve, Control
Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.
Lean
Lean categories of waste.
Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing
Lean-Six Sigma belt designation for those who understand the basics.
Yellow Belt
Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.
Green Belt
Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.
Black Belt
Lean-Six Sigma belt designation for experienced advisers and coaches.
Master Black Belt
Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.
Quality Assessment/Quality Assurance
Phase involving test requisition, patient preparation, specimen collection, and transport.
Pre-analytical
Phase involving reagents, equipment maintenance, calibration, and quality control.
Analytical
Phase involving calculation verification, delta checks, reporting, and interpretation.
Post-analytical
Algorithm comparing current lab results to previous results from the same patient.
Delta Check
Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.
Six Sigma
Indicators of Six Sigma performance improvement.
Improved performance, quality, bottom line, customer, and employee satisfaction
Five steps of Six Sigma (DMAIC).
Define, Measure, Analyze, Improve, Control
Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.
Lean
Lean categories of waste.
Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing
Lean-Six Sigma belt designation for those who understand the basics.
Yellow Belt
Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.
Green Belt
Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.
Black Belt
Lean-Six Sigma belt designation for experienced advisers and coaches.
Master Black Belt
Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.
Quality Assessment/Quality Assurance
Phase involving test requisition, patient preparation, specimen collection, and transport.
Pre-analytical
Phase involving reagents, equipment maintenance, calibration, and quality control.
Analytical
Phase involving calculation verification, delta checks, reporting, and interpretation.
Post-analytical
Algorithm comparing current lab results to previous results from the same patient.
Delta Check
Lean-Six Sigma belt between Yellow and Green belts.
Blue Belt
Phase where errors like inappropriate test requests, illegible handwriting, and delayed orders occur.
Pre-analytical
Phase where errors like incorrect tube, patient ID, or specimen volume occur.
Specimen acquisition (Pre-analytical)
Phase with issues like instrument calibration problems, interfering substances, or contaminated controls.
Analytical measurement
Phase where poorly written procedures and reagent deterioration can affect results.
Analytical measurement
Phase where errors like illegible, delayed, or incorrect transcription of reports occur.
Test reporting (Post-analytical)
Phase where interfering substances are not recognized or precision limitations are overlooked.
Test interpretation (Post-analytical)
Error in the pre-analytical phase caused by incorrect specimen transport conditions.
Improper transport conditions
Analytical phase error caused by poorly written procedures and calibration errors.
Instrument not calibrated correctly
Post-analytical error when previous values are unavailable for comparison.
Previous values not available
Phase where incorrect specimen collection time or conditions affect results.
Specimen acquisition (Pre-analytical)
Error caused by contaminated control solutions or deteriorating reagents.
Analytical measurement
Phase with errors involving inappropriate sensitivity, specificity, or recognition of test limitations.
Test interpretation (Post-analytical)
Ability to maintain accuracy and precision over an extended period despite changes in equipment, reagents, and personnel.
Reliability
Closeness of a result to the true or actual value.
Accuracy
Ability to produce closely agreeing results, expressed as coefficient of variation.
Precision
Type of precision measured within a single run.
Repeatability (Within-run precision)
Precision measured between runs or laboratories.
Reproducibility (Between-run/Interlab precision)
Number of control levels analyzed daily in internal quality control.
At least 2 levels every 24 hours
Duration required to establish initial control limits in internal QC.
At least 20 consecutive days or runs
Blind samples periodically sent to laboratories to test performance.
External Quality Assessment/Proficiency Testing (NEQAS)
Regulatory body sending unknown concentration analytes to participating laboratories.
National Reference Laboratory
Formula for the standard deviation index (SDI).
(Lab Result − Group Mean) / Group SD
SDI value indicating poor laboratory performance.
SDI > 2
Error caused by unpredictable chance events, affecting precision.
Random Error
Westgard rules violated by random error.
1(2s), 1(3s), R(4s)
Example causes of random error.
Improper sample mixing, pipetting error, temperature fluctuations
Error that occurs in a predictable pattern, influencing results in one direction.
Systematic Error
Westgard rules violated by systematic error.
2(2s), 4(1s), 8(1s), 10(mean)
Systematic error affecting all results regardless of analyte concentration.
Constant Error
Systematic error proportional to the analyte concentration.
Proportional Error
Examples of causes for systematic error.
Reagent deterioration, calibration error, dirty photometer
Type of error caused by faulty instrument stability, e.g., voltage fluctuations.
Random Error