Quality Management Flashcards
All laboratory’s policies, processes, procedures, and resources needed to achieve quality testing.
Quality Management System
The overall process of guaranteeing quality patient care and is regulated throughout the total testing system.
Quality assessment
What organization replaced the terms of the three stages of testing into preanalytical, analytical, and postanalytical?
International Organization for Standardization
What stage of testing occurs before the actual testing of the specimen?
Preanalytical
What stage of testing directly affects the testing of specimens?
Analytical
What stage of testing affects the reporting of results and correct interpretation of data?
Postanalytical
Enumerate all accreditation agencies requiring documentation of QA procedures.
Joint Commission (JC)
College of American Pathologists (CAP)
American Association of Blood Banks (AABB)
American Osteopathic Association (AOA)
American Society of Histocompatibility and Immunogenetics (ASHI)
Commission on Laboratory Assessment (COLA);
What refers to the amount of time required from the point at which a test is ordered until the results are reported?
Turnaround Time (TAT)
The sample that is chemically and physically similar to an unknown specimen and is tested in exactly the same manner.
Control
Identify the Quality Control:
- Testing control material not built into test system.
External QC
Identify the Quality Control:
- QC that extend beyond the system
External QC
Identify the Quality Control:
- Proficiency testing program
External QC
Identify the Quality Control:
- electronic, internal, or procedural controls that are built into test system.
Internal QC
Identify the parameter of QC:
- Nearness or closeness of assayed value to the true or target value
Accuracy
Identify the parameter of QC:
- Give repeated results on the same sample that agree with one another.
Precision
Identify the parameter of QC:
- Measure the smallest concentration of the analyte of interest.
Sensitivity
Identify the parameter of QC:
- Ability to measure only the analyte of interest.
Specificity
Enumerate the measures of center.
Mean
Median
Mode
What refers to the materials, procedures, and techniques that monitor the accuracy, precision, and reliability of a laboratory test?
Quality Control
Enumerate the indication of changes in accuracy.
Trend and Shift
What refers to the gradual changing in the mean in one direction?
Trend
What refers to the abrupt change in the mean?
Shift
Identify the Quality Control:
- verify the accuracy (ability to obtain the expected results) a precision (ability to obtain the same results on the same specimen) of a test
External Quality Control
Identify the measure of center.
- average of all data points
Mean
Identify the measure of center.
- data point that separates the upper half from the lower half of a data series
Median
Identify the measure of center.
- data point that appears most often in the sample
- not a true measure of central tendency
Mode
- Statistical parameters decribing spread of data.
- Measurement of precision
Measures of Dispersion
Enumerate the measures of dispersion.
Standard Deviation (SD)
Coefficient of Variation (CV)
Range
Identify the measures of dispersion.
- a measurement statistic that describes the average distance each data point in a normal distribution is from the mean.
Standard Deviation
Identify the measures of dispersion.
- the SD expressed as a percentage of the mean.
Coefficient of Variation (CV)
Identify the measures of dispersion.
- indicates whether the distribution of values about the mean is in a narrow versus broad range and should be less than 5%.
Coefficient of Variation (CV)
Identify the measures of dispersion.
- Difference between highest and lowest values in data set.
Range
Identifies and evaluates potential problems that may occur in the entire testing process from reexamination through the examination and post-examination processes.
Risk Assessment
Establishes control procedures to reduce the possibility of reporting an inaccurate patient test result.
Quality Control Plan
What study verifies the accuracy of the new method?
Correlation study
The testing of samples from an outside agency and the comparison of results with participating laboratories is called:
Proficiency testing (PT)
These are set of instructions for methods used in the laboratory.
Standard Operating Procedure (SOP)
Process of testing and adjusting analyzer’s readout to establish a correlation between measured and actual concentrations.
Calibration
Reference material with a known concentration of an analyte.
Calibrator
Testing materials of known concentrations to ensure the accuracy of results throughout the reportable range.
Calibration verification
A color change that indicates that a sufficient amount of the patient’s specimen or reagent is added correctly to the test system would be an example of:
A. External QC
B. Equivalent QC
C. Internal QC
D. Proficiency testing
C. Internal QC
What steps are taken when the results of reagent strip QC are outside of the stated confidence limits?
A. Check the expiration date of the reagent strip B. Run a new control
C. Open a new reagent strips container
D. All of the above
D. All of the above
When a new bottle of QC material is opened, what information is placed on the label?
A. The supervisor’s initials
B. The lot number
C. The date and the laboratory worker’s initials
D. The time the bottle was opened
C. The date and the laboratory worker’s initials
When control is run, what information is documented?
A. The lot number
B. Expiration date of the control
C. The test results
D. All of the above
D. All of the above
True or False.
Changes in precision are shown by a large amount of scatter about the mean and an uneven distribution above and below the mean that is most often caused by errors in technique.
True
