QUALITY CONTROL:

NOTES:
➢ Comparison of Anaytical Methods (Method Evaluation)
➢ The test method must be compared always with a method of acceptable
accuracy such as the standard reference method (gold standard)
➢ It is recommended by Westgard et al., and Clinical Laboratory
Improvement Amendments (CLIA) that 40 to 100 samples be run by each
method in duplicate on the same day over 8-20days, ideally within 4
hours, to determine accuracy and precision.
➢ Duplicate analyses of each sample by each method (test method and
reference method) are recommended, with the duplicate samples
analyzed in different runs and in different order of analysis on the two
runs (should be performed within 4hours)
➢ The rationale for performing repeated assays is to detect random errors
that affect precision.
➢ After analyses, samples with wide difference should be repeated to rule
out technical errors as the source of variation.

VARIATIONS:
➢ Are errors encountered in the collection, preparation, and measurement
of samples, including transcription and releasing of laboratory result.

Types of Error
1. Random Error
o It is present in all measurements; it is due to chance.
o It is a type of error which varies from sample to sample
o Basis for varying differences between repeated measurements-
variations in technique.
o Due to instrument , operator and environmental conditions
(variations in techniques) such as pipetting error, mislabeling of
samples, temperature fluctuation, and improper mixing of sample
and reagent
o
2. Systematic Error
o It is an error that influences observations consistently in one
direction ( constant difference)
o It is detected as either positive or negative bias –often related to
calibration problem deterioration of reagents and control materials,
improperly made standard solutions, contaminated solutions,
unstable and inadequate reagents blanks, leaky ion selective
electrode(ISE), failing instrumentation and poorly written
procedures.
 o Measure of the agreement between the measured quantity and true
value

a. Constant error
-referes to a difference between the target value and assayed
value
- it is independent of sample concentration
- it exists when there is a continual difference between the
comparative method and the test method regardless of the
concentration.
b. Proportional/Slope/Percent Error
- it results greater deviation from the target value due to
higher sample concentration.
- it exist when the difference between the test method and
the comparative method values is proportional to the analyte
concentration.
3. Clerical Error
o It is the highest frequency of clerical errors occurs with the use of
handwritten labels and request forms

Preanalytical errors:
1. Incorrect patient identification
2. Improper patient preparation
3. Incorrect specimen collection
4. Mislabeled specimen
5. Incorrect order of draw
6. Incorrect used of tubes for blood collection
7. incorrect anticoagulant to blood ratio
8. Improper mixing of blood anticoagulant
9. Incorrect specimen preservation
10. Mishandled specimen (transport and storage)
11. Incorrectly interpreted/ordered laboratory test
12. Incomplete centrifugation
13. Incorrect data log-in

Analytical Errors:
1. Incorrect sample and reagent volume
2. Incorrect incubation of solution
3. Equipment/instrument malfunction
4. Improper calibration of equipment/ calibration error

Post-analytical errors:
1. Unavailable or delayed laboratory results
2. Long turnaround time
3. Incomplete laboratory results
4. Wrong transcription of the patients data and laboratory results
5. Mising laboratory results
6. Laboratory result submitted to the wrong physician/doctors who did not
request for the lab test.

Notes to remember:
➢ Preanalysis refers to all the activities that take place before testing,
such as test ordering and sample collection
➢ The most frequent preanalytic errors to include improperly filling
the sample tube, placing specimens in the wrong containers ore
preservatives, and selecting incorrect test
➢ The analysis stage consist of the laboratory activities that actually
produce a result, such as running a sample on an automated
autoanalyzer. Post analysis comprises patient reporting and result
interpretation.
➢ The length of time elapsed between drawing and the separation of
serum or plasma from the cells can be a factor in analytic testing,
➢ Nonlaboratory personnel were responsible for 29% errors with
regard to laboratory result
➢ Online computer input is the most error free means of requesting
laboratory test
➢ Most laboratory errors occur in pre analytic and post analytic
stages

TERMINOLOGIES:

1. qualitative - giving either positive or negative test results (a binary response)

2. medical decision level - the concentration or limit at which the test results are critically
interpreted
3. sensitivity - the ability to detect small concentrations of the measured analyte
4. specificity - freedom from interference and cross reactivity, to determine solely the
analyte purported to be measured
5. screening test - test to determine if patients have a disease before they present with
symptoms; should be very sensitivity
6. confirmatory test - using laboratory tests to verify that an initial test result is accurate;
should be very specific
7. medical decision limit - the value for a test result that is used in making the diagnosis
8. reference method - a thoroughly investigated method with documented accuracy and
precision
- test method that provides the best agold standard method vailable approximation of a
true value
9. diagnostic sensitivity - the likelihood that, given the presence of disease, an abnormal
test result predicts the disease ; is the ability of the test to detect the proportion of
individuals with that disease who test positively with the test
 10. true negative - result below the decision limit in a patient who does not have the
disease
11. false negative - result below the decision limit in a patient who has the disease
12. true positive - result at or above the decision limit in a patient who has the disease
13. Imprecision – used to express how far apart numerical values from each other .
14. Result – outcome of a diagnostic test performed in the medical lab .
15. false positive - result at or above the decision limit in a patient who does not have the
disease
16. Practicability – the degree by which a method is easily repeated
17. Reliability – the ability of the analytical method to maintain accuracy and precision over
an extended period of time during which equipment , rgnts and personnel may change

Important:
READ CHAPTER 4: METHOD EVALUATION & QUALITY MANAGEMNT (Reference: Bishop)

Dear Student:
“Its okay it’s part of the learning process just remember an expert was once a beginner!” ☺