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6 - Module 7 (Quality Assurance Asessment)

Medical Technology (Southwestern University PHINMA)

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Clinical Chemistry
1:00-3:00PM MWF | 9:00:10:00AM TTHS | NENITA EUSTAQUIO
MODULE 7 → Material is usually run at the beginning of each shift;
after an instrument is serviced; when reagent lots are
TOPIC OUTLINE changed; after calibration, and when patient results
1 Quality Assurance/Assessment seem inappropriate
a. Quality Control → Quantitative tests should include a minimum of one
b. Laboratory Quality Control control with a target value in the healthy person
c. Types of Quality Control reference interval and a second control with a target
d. Pre-Analytical and Analytical Causes of Error value that would be seen in a sick patient
e. Post-Analytical Causes of Error - Examples include sodium controls of 140 and
2 Statistics 115 mEq/L and glucose controls of 75 and 225
a. Statistical Analysis of Lab Test Data mg/dL.
b. Measures of Central Tendency - If three control levels are run, an abnormally
i. Mean low patient range should be included
ii. Median → Must be integrated within routine workload and
iii. Mode analyzed by personnel who are running the tests
c. Precision and Accuracy → Ongoing evaluation of results to correct for
d. Systematic Error unacceptable results
i. Causes of Systematic Error → Used to access employee competency
e. Random Error
i. Causes of Random Error TYPES OF QUALITY CONTROL
f. Bias INTERNAL
g. Analytical Measurement Range → Daily establishment of reference ranges
h. Clinical Reportable Range → Validation of a new reagent lot and/or shipment
i. Statistical Formula → Following instrument repair
j. Standard Deviation and Probability EXTERNAL
k. Statistical Formulas → Determination of laboratory testing performance by
l. Establishment of a QC System means of intralaboratory comparisons
m. Collecting Data for Quality Control → CAP, CLIA, The Joint Commission requirement
n. Shift, Trend, and Out of Control
o. System Flags PRE-ANALYTICAL AND ANALYTICAL CAUSES OF ERROR
i. Delta Check
ii. Critical Values and Read Back of Results

QUALITY ASSURANCE/ASSESSMENT
→ An all-inclusive / comprehensive system monitoring the
accuracy of test results where all steps before, during and
after the testing process are considered
→ Includes:
✓ Pre-analytic
✓ Analytic
✓ Post analytic factors
→ Essentials include commitment to quality, facilities, POST-ANALYTICAL CAUSES OF ERROR
resources, competent staff, and reliable procedures, → Incorrect reference values
methods and instrumentation → Physician not notified of a panic or critical value
→ Provides a structure for achieving lab and hospital quality → Incorrect interpretation of lab results by physician
goals → Incorrect data entry of lab results

QUALITY CONTROL STATISTICS

→ Is a measure of precision or how well the → Is a (science of) branch of mathematics that collects,
measurement system reproduces the same result over analyzes, summarizes, and presents information about
time and under varying operating conditions “observations”
→ In the clinical lab, these “observations” are usually
LABORATORY QUALITY CONTROL numerical test results
→ Is designed to detect, reduce, and correct deficiencies
in a laboratory’s internal analytical process prior to the STATISTICAL ANALYSIS OF LAB TEST DATA
release of patient results and improve the quality of the → Can help us to define:
results reported by the laboratory

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Clinical Chemistry
1:00-3:00PM MWF | 9:00:10:00AM TTHS | NENITA EUSTAQUIO
1 Reference ranges for patient’s (normal and → Systematic error of an analytic system is predictable
abnormal) and causes shifts or trends on control charts that are
2 Acceptable ranges for control specimens (“in” and consistently low or high
“out” of control) CAUSES OF SYSTEMATIC ERROR
1 → Change in reagent or calibrator lot numbers
MEASURES OF CENTRAL TENDENCY 2 → Wrong calibrator values
MEAN (x) 3 → Improperly prepared reagents
→ The mathematical average of a group of numbers, 4 → Deterioration of reagents or calibrators
determined by adding a group of numbers (events) and 5 → Inappropriate storage of reagents or calibrators
dividing the result by the number of events 6 → Variation in sample or reagent volumes due to
MEDIAN pipettor misalignments
→ Determined as the ‘middle’ of a group of numbers 7 → Variation in temperature or reaction chambers
that have been arranged in sequential order 8 → Deterioration of photometric light source
→ That is to say, there are an equal number of numbers 9 → Variation in procedure between technologists
on either side of the ‘middle’ number
→ In an odd # of observations, it is the middle RANDOM ERROR
observation → Imprecision of the test system causing a scatter or
→ In an even # of observations, average the two middle spread of control values around the mean
values CAUSES OF RANDOM ERROR
MODE 1 → Air bubbles in reagent
→ The number that appears most frequently in a group 2 → Improperly mixed reagents
of numbers 3 → Reagent lines, sampling, or reagent syringes
→ There can be more than mode, or none at all 4 → Improperly fitting pipette tips
5 → Clogged or imprecise pipetter
PRECISION 6 → Fluctuations in power supply
→ The degree of fluctuation in the measurements is
indicative of the precision of the assay
BIAS
→ Precision-refers to the ability to get the same (but not
→ The amount by which an analysis varies from the
necessarily ‘true’) result time after time
correct result
ACCURACY
→ Example:
→ The closeness of measurements to the true value is - If the Expected Value is 50 units, and the result
indicative of the accuracy of the assay of an analysis is 47, the bias is 3 units.
→ An accurate result is one that is the ‘true’ result
ANALYTICAL MEASUREMENT RANGE
→ Range of analyte values that a method can directly
measure on the specimen without any dilution,
concentration or other pretreatment

CLINICAL REPORTABLE RANGE

→ Range of analyte values that a method can directly
measure on the specimen without any dilution,
concentration or other pretreatment

STATISTICAL FORMULA

SYSEMATIC ERROR
→ Systematic change in the test system resulting in a
displacement of the mean from the original value

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Clinical Chemistry
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STANDARD DEVIATION AND PROBABILITY

→ For a set of data with a normal distribution, a value
will fall within a range of:
✓ +/- 1 SD 68.2% of the time
✓ +/- 2 SD 95.5% of the time
✓ +/- 3 SD 99.7% of the time
USE OF STANDARD DEVIATION
→ Once you have determined the standard deviation,
must use the information to evaluate current/ future
analysis
→ Most labs make use of ± 2 SD or 95% confidence limit.
To put this into a workable form, you must establish the
range of the ± 2 SDs
STATISTICAL FORMULAS
COEFFICIENT OF VARIATION CONTROL CHART
→ Indicates what percentage of the mean is → Also known as the ‘Shewhart chart’ or ‘process-
represented by the standard deviation behavior chart’ is a statistical tool intended to assess the
→ Reliable means for comparing the precision or SD at nature of variation in a process and to facilitate
different units or concentration levels forecasting and management
→ Expressed as a percentage
𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑 𝑑𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛 LEVEY-JENNINGS CHART
𝐶𝑉% = 𝑥 100 → A graphical presentation used in interpreting quality
𝑀𝑒𝑎𝑛
→ The smaller the CV, the more reproducible the control data
results: more values are closer to the mean The dates of analyses are plotted along the X-axis and
→ Useful in comparing 2 or more analytical methods control values are plotted on the Y-axis. The mean and
→ Ideally should be less than 5% one, two, and three standard deviation limits are also
marked on
ESTABLISHMENT OF A QC SYSTEM the Y-axis.
→ Two or three levels of control material used The distance from the mean is measured in standard
CONTROL deviations (SD). Lines run across the graph at the mean,
→ Control is a material or preparation used to monitor as well as one, two and sometimes three standard
the stability of the test system within predetermined deviations either side of the mean. This makes it easy to
limits see how far off the result was
MEASURE OF PRECISION AND RERODUCIBILITY
→ Purpose: verify the analytic measurement range of WESTGARD RULES
instrument for a specific analyte → Can be applied to see whether the results from the
A CONTROL MATERIAL MATRIX SHOULD RESEMBLE samples when the control was done can be released, or
ACTUAL SPEICMENS TESTED if they need to be rerun
1 → Lyophilized/liquid → It is used to define specific performance limits for a
2 → Assayed particular assay and can be used to detect both random
- Mean calculated by the manufacturer and systematic errors
- Must very in the laboratory → Are programmed into automated analyzers to
3 → Unassayed determine when an analytical run should be rejected
- Less expensive
- Must perform data analysis in house

COLLECTING DATA FOR QUALITY CONTROL

CHARTING TECHNIQUES
→ Levey Jennings Chart
- Is a graph that plots QC values in terms of how
many standard deviations each value is from the
mean

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Clinical Chemistry
1:00-3:00PM MWF | 9:00:10:00AM TTHS | NENITA EUSTAQUIO
SHIFT
→ QC data results are distributed on one side of the
mean for 6-7 consecutive days
TREND
→ Consistent increase or decrease of QC data points
over a period of 6-7 days
OUT OF CONTROL
→ Means that there is too much dispersion in your result
compared with the rest of the results
→ This suggests that something is wrong with the
process that generated that observation
→ Patient test results cannot be reported to physicians
when there is something wrong with the testing process
that is generating inaccurate reports
→ Remember … No information is better than wrong
information
WHAT IF YOUR CONTROL SPECIMEN IS OUT OF
CONTROL?
Things that can go wrong Corrective action
Instrument malfunction Identify malfunction and fix
Reagents: preparation, New reagents
contamination, volume
Tech error Identify error and repeat
test
Control specimen is old Use new control
or prepared improperly

SYSTEM FLAGS
DELTA CHECK
→ Comparison of individual patient results throughout
the day or week with computer detection of changes
from earlier individual patient results
→ Helpful to identify pre-analytical errors
CRITICAL VALUES AND READ BACK OF RESULTS
→ Values that indicate a life-threatening situation for
the patient
→ Require notification of the value to nurse or physician
→ Nurse or physician must “read back” the results to the
technician

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