INTRODUCTION TO QUALITY CONTROL & QUALITY ASSURANCE

Objectives:
Describe the use and principles of quality

assurance and quality control in a laboratory

Describe the factors that ffect quality

assurance while performing laboratory work.

Explain the Levey-Jeennings chart Terminology used in quality control and

quality assurance

Definitions:
Quality assurance(QA):

Refers to all the steps which is involved in the reporting

of a correct laboratory result Quality control(QC): Refers to measures that should be included to verify a test procedure/method Quality assessment: Monitors the effectiveness of the QA & QC

It can be Internal or External

Factors which affect the quality of result:

The educational background of the laboratory

technologist
Conditions of the specimens The controls used in the testing Reagents and Equipments The interpretation of test results, Transcription of

results and Reporting of results

QUALITY ASSURANCE
Quality assurance The right result at the Right time, on the Right specimen, from The right patient , with the result

interpretation based on
Correct reference data , and at the

Right price

QA involves monitoring:
The process of monitoring instruments Reagents Test procedures Technologist performance The accuracy of reported results

QUALITY CONTROL
It involves the control of errors in the

performance of tests and verification of

test results.
QC should :
Practical
Achievable Affordable

 QC monitors the performance of any analytical

system.
Analytical system consists :
Instruments Reagents Calibrators Controls Samples Operator technique(SOPS)

ACCURACY AND PRECISION

Accuracy:

It is the ability to reproduce or realize the

true value of a population attribute.

Precision:
Precision is also a measure of performance It is the ability to obtain the same results time

after time, on the same sample

STANDARDS AND CONTROL SERA

To validate results all the analytical

instruments should be calibrated and controls

must be run with each set of patient samples

Calibration can be accomplished either by

analyzing solutions of known composition

known standards.

CONTROLS
It is solution that contains the same constituents

as those being analyzed in the patient sample.

It should be analyzed along with patient sample,

using the same method ,test conditions and reagents.

A normal and an abnormal control should be run.

Each days results are used to construct a QC

record called the Levey-Jennings chart.

Control sera are available in the following forms:

1. Lypholyzed/ freeze dried
2. Pre- diluted form( ready to use) 3. Ethylene-glycol- based controls ( should not be

used on analytes measured by ion-specific

electrodes). These are stored at 0C

Standard Deviation:
68.2% chance, a control result will fall

within +/- 1 SD
95.5% chance, a control result will fall

within +/- 2 SD
99.7% chance, a control result will fall

within +/- 3SD

 If a laboratory result fall outside the quality

control result range, it is called __________ Levey-Jennings Charts:

- Used to determine whether the method is in-

control
- Each level of control will have a different

quality control chart

STANDARD
It is a substance that has an exact known value

and that, when accurately weighed or measured

, can produce a solution of an exact

concentration
Standards can be called as reference materials

Standards:
They are used when:
Calibrating an instrument in the installation Re-calibrate after repair or according to

manual
If the analytical values are out of control

CALIBRATION
Calibrators are used to standardize machines

Calibration involves checking the performance

of machines before sample is being analyzed

and results issued.

It is process of comparing instrument response

to known physical properties such as electronic

signals(cell counters) and light spectra (spectrophotometers)

 It varied from instrument to

instrument.
What is the advantage of using

assayed commercial controls?

ERRORS AFFECTING THE RESULT:

1. Errors of scatter (imprecision)

These are irregular or random errors. Not due to method but may be due to technique

5 /100 fall out of 2SD range.

2.

Errors of bias (inaccuracy) These are systemic error, all samples are affected May be due to reagent deterioration/calibration

FACTORS AFFECTING QUALITY ASSURANCE

1. Specimen collection 2. Calibration and quality control 3. Instrument operation /maintenance 4. Patient result handling (interpretation and reporting

of test results)

PREVENTIVE MAINTENANCE OF EQUIPMENT

Poorly maintained analytical equipments and

instruments can affect the quality of results.

Maintenance is important to ensure effective

and efficient functioning of laboratory equipments and instruments.

ADVANTAGES OF PPM
Maintain high level of performance Less unexpected shut down time during

operation
Lengthening instrument
Improve the technologists knowledge of how

the equipment works and how to maintain it

Lower repair costs

QUALITY CONTROL ON DIAGNOSTIC TEST PROCEDURES

A QC programme should be implemented on all

the laboratory procedures.

It is a statistical system for measuring the

reproducibility of degree of precision in the laboratory procedure.

The program ensures the physicians and

patients, quality results

STANDARD DEVIATION, VARIANCE & MEAN

STANDARD DEVIATION :is measure of the

scatter of the sample values around mean

It can be derived with the calculation of the

variance
It can be used to calculate the acceptable

variance of the given test procedure.

CALCULATING THE MEAN

By calculating the average of a set of values Calculate the mean for the following values?

The values were obtained after repeated

analysis for a glucose control serum:

82,85,90,81,86,94,89

Median & Mode:

Median:
Central number in the sequence of numbers Equal amount of numbers are above and

below the median value

Mode:
Number that occurs most frequently in a

sequence

Gaussian Distribution:
When mean, median and mode are all the

same number it is said that the numbers are having a Gaussian Distribution or Normal Distribution

Gaussian Distribution Curve:

Variance:
Indicates how far apart from each other, or

how precise are the number within a group.

VARIANCE(s2)=(mean-value)2
n-1

CALCULATING THE STANDARD DEVIATION

Calculate the variance

Symbol of variance is S2
Calculated by subtracting each value from the mean

value and taking the square of it and the sum of which is divided by n-1

(where n is the total number of values)

STANDARD DEVIATION is calculated by taking the

root of the variance.

FORMULAR - Variance
STANDARD DEVIATION(s)=root of variance
CALCULATE THE 1S 2S and the 3S values if the s=

4.11
1s,-1s,2s,-2s,3s,-3s

CHART THE VALUES IN LEVEY JENNINGS CHART

Mark the x-axis as the concentration Mark the y-axis control 1-10 Mark the 1s 2s and 3s respectively on the x-axis
The chart should show a fairly even distribution

of values on each side of the mean within +2SD

and -2SD.

USING THE LEVEY-JENNINGS CHART

Daily run control for each batch of samples

Chart them on a daily control chart

See if the values are within the +2SD

INTERPRETATION OF RESULTS
CONTROL VALUE WITHIN THE +2SD
It means the patient results are reliable

CONTROL VALUE OUTSIDE THE +2SD

Means that the results are un acceptable Patient report should not be given Run a control again and the patient sample Still it is not falling within the 2SD range, do not

report the patient results

IDENTIFICATION OF ERRORS
Reagent deterioration or the incorrect

preparation of a working reagent.

Faulty equipment
Wrong filter may be used.

Wrong method
Environmental conditions

TRENDS AND SHIFTS IN THE CHART

TREND
It is when the control value constantly increase or decrease

over a period of time. (6 to 7 days)

3-4 values are always high/low Occurs slowly It tell you that there is an error:

In the instrument
The technique The reagents

SHIFT
A Shift is when a majority of values fall on one side

of the mean, for a consecutive 6 to 7 days

It tell you that there is an error/systemic error
In the instrument The technique The reagents

TRENDS AND SHIFTS must be investigated. Run control with a new lot number of control sera. If error persists re-calibrate your machine.

TREND

WESTGARDS RULES
It is a guideline to decide a whether a

method/procedure is out of control.

To use the guideline all laboratories should

run and normal and an abnormal control sera.

A RUN OUT OF CONTROL

1. Both controls are outside the +2SD

2. The same control level is outside the +2SD

successive runs
3. Controls in four consecutives runs have values

greater than +1SD all in the same direction.

4. Ten consecutive control values fall on the one side

of the mean.

Warning rule or 12s rule

The first number denotes the number of

quality control results.

The subscript refers to the Westgard rule

that is being violated.

Violated when either of the two controls

exceeds 2SD from the mean in a either a

positive or negative direction.

The 13S Rule

The 13s rule is violated when the result of

one of the two QC results is outside of

3SD.
The result is Out of control

Repeated / Reported
Due to random error

The 22s Rule

If both results falls or if one results for

consecutive days falls outside 2SD range 41s Rule: One control falls on the same side of the mean and exceed +/- 1SD, for four consecutives runs Two control/two consecutive runs

The 10x rule:

- 10 consecutives runs ( for one QC )

results falls on the same side of the mean

- Results fall in on the same side of the

mean for both levels of control for 5 days.

REPORTING PATIENT RESULTS

Patient results can be reported if the values are

IN-CONTROL

QA- Quality Assurance

USES:
Monitoring factors that may affect the quality of

laboratory test results.

For correcting any deficiencies found during the

monitoring process
For reevaluating the system after corrections To inform staff of any procedural changes

THE VARIABLES IN THE QA

Pre-analytical variables Analytical variables Post-analytical variables

PRE-ANALYTICAL VARIABLE
Controlled before testing
Misidentifying the patient Collecting a sample at the wrong time Mishandling the specimen

CONTROLLING THE VARIABLE:

Selection of appropriate tests Identification and preparation of the patient

Collecting and labeling of the sample

Transport of the sample to the laboratory Proper handling of the sample from the time of collection until

the time of testing

Placement of sample in the laboratory work load Storage of reagent used to perform tests Periodically verifying that procedure manuals are complete

and up to date

ANALYTICAL VARIABLES
During the test procedure:
Random error-cause not identified. Systemic error-make results high/low consistently

RANDOM ERROR:
An air bubble in a reagent line Difference in technique among workers Certain specimen characteristics

SYSTEMIC ERROR
Deteriorated reagents Mechanical trouble in the instrument

Peculiarity in worker methodology

eg; incorrect pipetting

POST ANALYTICAL
Errors which occur after the test procedure:

TERMINOLGY Find the meaning of the following according to QA & QC:

Population Sample Parameter Statistic Maximum value Range The mean Median Mode Minimum value.