Quality In The Laboratory Flashcards
A management philosophy and approach that focuses on processes and their improvement as the means to satisfy customer needs and requirements.
Total Quality Management (TQM)
It include analytical processes and the general policies, practices, and procedures that define how all aspects of the work are done.
Quality Laboratory Processes (QLP)
Emphasizes statistical control procedures (QC procedures), but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors.
Quality control
Concerned primarily with broader measures and monitors of laboratory performance
Quality Assessment
Provides a structured problem-solving process to help identify the root cause of a problem and a remedy for that problem.
Quality Improvement
“set of key and quality elements that must be in place for an organization’s work operations to function in a manner to meet the organization’s stated quality objectives.”
Quality Management System
A comprehensive program in an institution in which all areas of operation are monitored to ensure quality with the aim of providing the highest quality patient care.
Quality Assurance
Set of instructions for methods used in the laboratory. Also known as procedure manual
Standard Operating Procedures
Training, Calibration and Maintenance are examples of what quality costs:
Prevention cost
Inspection and Quality Control are examples of what quality costs:
Appraisal costs
Scrap, Rework and Repeat runs are examples of what quality costs:
Internal failure costs
Complaints, Service and Repeat Request are examples of what quality costs:
External Failure Costs
Increasingly used to reduce error (Six Sigma) and waste (Lean)
Lean Six Sigma
The major measurement for Lean:
Time
A performance improvement program, the goal of which can be summarized by the mantra “improvement by eliminating process variation”: improved performance, improved quality, improved bottom
line, improved customer satisfaction, and improved employee satisfaction . it is oriented toward process identification and process improvement.
Six Sigma
Process improvement in six sigma
DMAIC
Define
Measure
Analyze
Improve
Control
A system ensuring accuracy and precision. It is used to monitor the analytic variations that can occur with a new instrument or with new lots of control.
Quality control
Measures the smallest concentration
Sensitivity
Ability to measure only the analyte of interest
Specificity
Nearness or closeness of the assayed value to the true value
Accuracy
Ability to give repeated results on the same sample that agree with one another
Precision/Reproducibility
High SD and CV
Poor precision
Low SD and CV
Good precision
Refers to the ability of laboratory testing to maintain accuracy and precision over an extended period of time.
Reliability
Ability to detection proportion of individuals w/that disease.
Diagnostic Sensitivity
The percentage of people with positive test results who have the disease.
Positive predictive value
Ability to detect the proportion of individual w/o the disease who test negatively for the disease.
Diagnostic specificity
The percentage of people with negative test results who do not have the disease
Negative predictive value
Determines the lowest and highest values that can be accurately measured by a particular method.
Linearity check
A quality program in which specimens are submitted to laboratories for analysis and the results of an individual laboratory are compared with the results for the group of participating laboratories.
External quality assessment
Specimens that have known concentrations of an analyte for the test of interest. The testing laboratory does not know the targeted concentration when tested.
Proficiency samples
Analyses of control w/patient sample
Intralab
Due to chance. Arises from unpredictable variations of influence quantities. Error that doesn’t recur in regular pattern; affect precision.
Random error
Consistent in one direction or varies in a predictable way. Recurring error inherent in test procedure.
Systematic error
Handwritten labels and request forms
Clerical error
The science of gathering, analyzing, interpreting and presenting data
Statistics
Measure of central tendency, symmetrical or normal distribution
Mean
Difference between the observed mean and the reference mean
Bias
The middle value in a set of numbers that are arranged according to their magnitude
Median
The most frequently obtained value in a set of numbers
Mode
Measure of the dispersion of values from the mean . Reflects the variation of data values around the mean.
Standard Deviation
Percentile expression of the mean, an index of precision.
Coefficient of variation
Standard deviation squared, a measure of variability reflects dispersion around the mean
Variance
Indicate the extent of variation of the observations:
SD
Variance
Range
Where independent variable is plotted
Abscissa/X –axis
Where dependent variable is plotted
Ordinate/Y-axis
Data elements are Centered around the mean. Most common shape.
Gaussian Curve (bell shaped curved)
Difference between QC results and target mean. Requires computer.
Cumulative Sum Graph (CUSUM)
Used to compare results obtained Control results from different lab.
Youden/Twin plot
QC chart in the clinical lab
Shewhard Levey-Jennings Chart
Range within which control values must fall for assay to be considered valid.
Control limits
Obvious on the chart when control values become more disperse
Loss of precision
Control values that either increase or decrease for 6 consecutive days
Trend
Main cause of trend:
Expiring reagent
Control values that distribute on one side or side of the mean for 6 consecutive days
Shift
Main cause of shift:
Improper or wrong calibration
Far from the main set of values.
Outliers
A systematic error:
Trend and shift
Random or systematic error:
Outliers
Most commonly used patient based-QC technique.
Delta check
Most commonly used POCT
Glucose
