QUALITY ASSURANCE

Quality Assurance & Control

• Quality Assurance: comprehensive set of policies and procedures

 ensures accuracy and reliability
 Pre-Analytic
 Analytic
 Post-Analytic
 QC is only a part of QA

Quality Assurance measures taken to ensure the reliability of laboratory sampling, testing and reporting dependent on continuous
process of assessment and improvement

• IQC ensures precision and consistency of results for reporting

• EQA retrospective analysis comparing results between labs and between methods

Internal Quality Control (IQC) External Quality Assessment ( EQA)

• Set of procedures undertaken for continuously and • A.k.a proficiency testing

concurrently assessing laboratory work and
emergent results
• Decision levels for accepting results as reliable
enough for release
• It controls the laboratory output
• Main objective is ensure day to day consistency
• System of objectively assessing a lab performance
by an outside agency
• Retrospective and periodic assessment
• Main objective is to establish inter laboratory
comparability

QC

• To increase the probability that each result reported is valid

• Generate results that are reliable and precise
• Objectives of Quality Control
 To check the stability of the machine
 To check the quality of reagents
 To check for technical errors

QC TERMS
• Accuracy: closeness to the true value
• Precision: closeness of one value to another • Specificity
• Sensitivity
• Specificity and Sensi: Analytical and Clinical/Diagnostic
o Diagnostic Sensi: True Positive/ (TP+FP) *100
o Diagnostic Speci: True Negative/ (TN+FN)*100
• Practicability: reproducibility
• Reliability
• Delta Check

CLINICAL EFFICACY MEASUREMENT

• Diagnostic sensitivity = [TP/ (TP + FN)] x 100

- Proportion of px who have a dx who have a positive result
- Anal. Sensi : lowest amt of a subs that can be detected by a method
• Diagnostic specificity = [TN/ (TN + FP)] x 100
- Proportion of px who are identified correctly by the test as having the disease
- Anal. Speci : how well a test method detect a particular substance rather than similar ones

• PPV =[TP/ (TP+FP)] - Proportion of patients with a disease test result compared with all px who have a positive test result

• NPV =[TN/ (TN+FN)] - Proportion of patients w/o a disease who have a negative test result compared with all patients who have
a negative test result.

• Accuracy: determined by regression

• Precision: determined by std deviation and cv
Co-efficient of variation

• gives a true picture of deviation regardless of the nature of the measurement or

methodology
• Use to commonly describe the precision of the assay
• Signifies random errors or imprecision
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QC: Terms

• Reference Range: expected values; usual specific values for a healthy population
• Factors affecting Reference Intervals
 Composition of Reference Population
 Inclusion and Exclusion Criteria of the Reference Population > Physiologic and Environmental Conditions
 Specimen Collection
 Analytical Method

RELATIONSHIP BETWEEN SD AND THE NORMAL DISTRIBUTION CURVE

QC

• Types of Errors

 Random: accidental/indeterminate; affect precision

 pipetting errors
 mixing errors
 voltage, temperature errors
 Systematic: determinate; affects accuracy
 calibration errors; reagent deterioration, unstable blanks, poorly written procedures

METHOD PERFORMANCE
Qualitative Concept Quantitative Measure
Trueness Bias
“Closeness of agreement of mean value with true value” “A measure of the systematic error”

Precision Imprecision (SD)

“Repeatability (within run)” “A measure of the dispersion of random error”
“Intermediate precision (long term)”
Accuracy Error of measurement
“Closeness of agreement of a single measurement with true “comprises both random and systematic influences”
value”
1. Reference Materials
• Standard – substance has an exact known value; calibrators - accuracy
 Primary
 Secondary
• *calibrators : for some analytes w/c is impossible to prepare a standard (or there are just a handful of standards available)
2. Controls
• Contain same constituents as those being analyzed in the patient sample
• Precision
Characteristics
o Behave like real specimens
o Sufficient in amount and Convenient
o Must include Normal, Low and High Ranges
o Lyophilized
• Sources:
 Pooled
 Commercially Prepared
3. QC
• Control Chart: used to compare values for control materials with their known values
 x axis: Run Date
 y axis: Control Values
• Levey Jennings (Shewhart): commonly used

The Gaussian Distribution

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QC Calculations

• Number of control of measurements: 20 in a span of 2 weeks or 10 working days

QC Calculation Relation Formula

Mean: estimate of central tendency Related to Accuracy; Systematic Error

Standard Deviation: related to the Precision; Random Error

spread or distribution of control results
about the expected mean.

Coefficient of Variation: SD as a often provides a better estimate of

percentage method performance over a range of
concentrations.
How do you compute control limits? > Mean + or – the SD (i.e. 2SD)

Levey Jennings Chart

• Steps:
 Controls are run for at least 20 days. Mean and SD are computed
 Control Charts are constructed
• Run the controls (Normal and Pathologic); Plot the values on the chart
• When values fall within 2SD, it is in control and the results are valid
• If it falls outside 2SD, it is out of control, determine type of error and
Westgard rule violated
• If error is detected, check the ff:
 test method
 equipment
 reagents
 specimens

WESTGARD RULES

QC

• Shift: 6 or more control values are below or above the mean

 improper calibration
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• Trend: 6 or more control values passing through the mean
 deteriorating reagents

LABORATORY MATHEMATICS AND CALCULATIONS

Units of Measure • Unit defines physical quantity or dimension, such as mass, length, time, or volume
• Système Internationale d’Unités (SI)
o Adopted internationally in 1960
o Preferred in scientific literature and clinical labs
o Based on metric system
o Includes basic (m, kg, s) and derived (Hz, N, °C) units
o Uses standard prefixes: nano, micro, milli, kilo, mega, giga, tera
Concentration • Percent solution
Calculations • Molarity
• Normality
• Conversions
Dilutions Calculations • Simple dilutions
• Serial dilutions
Solutions Solute – substance that is dissolved in a liquid
Solvent – liquid in which the solute is dissolved
Solution – homogenous mixture of solute and solvent
Percent Solution • Is equal to parts per 100 or the amount of solute per 100 total units of solution

• Example 1a

• Example 1b

• Example 2a
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Molarity • The number of moles of solute per liter of solution

Example

Normality • The number of gram equivalent weight of solute per liter of solution

• Example
Compute for the Normality of a HCl solution given the following data:
o Weight of solute: 175 g
o Volume of Solution: 1500 mL
o MW of HCl: 36 g/mol
o Valence: 1

Ratio and Dilution Ratio

• The quantitative relation between two amounts
• Usually expressed using a colon (:)
• Ratio = Volume of Solute/Volume of Solvent

Dilution
• Represents the ratio of concentrated or stock material to the total final volume of a solution
• Usually expressed in ratio or in fraction
• Dilution = Volume of Solute/Volume of Solution
• Example
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Serial Dilutions • Multiple progressive dilutions ranging from more concentrated solutions to less
concentrated solutions

Correction for using a diluted sample

• Example
A technician performed a laboratory analysis of patient’s serum for a serum glucose (blood
sugar) determination. The patient’s serum glucose was too high to read on the glucose
instrument. The technician diluted the patient’s serum 1/2 and re-ran the diluted specimen,
obtaining a result of 210 g/dl.
• 210 g/dl x 2 = 420 g/dl.

Conversions
• Making fixed volumes of specific concentrations from liquid reagents
C1V1=C2V2
C1 = initial concentration
C2 = resulting concentration
V1 = initial volume
V2 = resulting volume

Activity: Problem Solving

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