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Quality Control

The document discusses quality control in medical laboratories, emphasizing the importance of quality assurance processes to ensure accurate test results. It outlines types of errors that can occur at pre-analytical, analytical, and post-analytical stages, and introduces quality control tools such as control charts and Westgard rules. Additionally, it highlights the need for quality control to reduce morbidity, economic loss, and to ensure laboratory credibility.

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2 views15 pages

Quality Control

The document discusses quality control in medical laboratories, emphasizing the importance of quality assurance processes to ensure accurate test results. It outlines types of errors that can occur at pre-analytical, analytical, and post-analytical stages, and introduces quality control tools such as control charts and Westgard rules. Additionally, it highlights the need for quality control to reduce morbidity, economic loss, and to ensure laboratory credibility.

Uploaded by

spurthisanda7
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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QUALITY CONTROL

BY DR.RISHIKULYA
DEPARTMENT OF BIOCHEMISTRY
• QUALITY: Conformance to satisfying the needs and expectation of
the customers
• Quality assurance is often used to refer to all the processes a
laboratory takes to ensure quality in test results. It is an overall
program to ensure proper test results.
• Quality Control in the medical laboratory is the statistical process
used to monitor and evaluate the analytical process that produces
patient results. It includes all the measures to be included in verify
that the tests is working properly.
• Quality control provides the tool to detect the problems early and to
prevent errors from exceeding established quality requirements.
• STANDARD: Standard is a solution at known concentration of analyte which
is used to calibrate (adjust) an assay method.
• CONTROLS: They are used to assess the performance of the assay once it
calibrated an assay method.
• Controls are run along with patient samples and the results are calculated
in the same way. They are run to check whether the results produced are
acceptable.
• The quality assurance frame work:
1. Definition of goals and objectives
2. Quality planning
3. Quality laboratory process
4. Quality assessment
5. Quality improvement
• Need of Quality control in lab:
1. Reduce morbidity
2. Reduce economic loss
3. Ensure credibility of lab
4. Generates confidence in lab results

• TRUE VALUE: Refers to the actual value of analyte being measured


• MEASURED VALUE: Refers to the concentration of the analyte that you
get of the test
• ACCURACY: Refers to the closeness of results with true value. It
indicates how well measurement agrees with the accepted value.
• PRECISION: Refers to reproducibility of the test results.It indicates how
well a series of measurement agree with each other. The results should
be accurate and precise.
• SENSITIVITY: The ability of a test to correctly identify patients with a
disease.
• SPECIFICITY: The ability of a test to measure solely the component of
interest without interference from other analytes
• FLAME EMISSION SPECTROPHOTOMETER: Measures light emitted by
excited atoms (Na,K,H)
• APPLICATIONS:
• Qualitative and Quantitative determinations such as enzyme assays,
molecular weight determission.
• Spectroscopic analysis is commonly studied in solutions,but solids ,
gases may also be studied.
• Useful in Pharmaceutical, food, paint industries.
• ADVANTAGES :
1. Can be used for colorless compounds
2. Work in UV, Visible and infrared regions
3. Specific wavelength can be set
4. More accurate
• DISADVANTAGES:
1. More expensive
2. Not transportable

TYPES OF QUALITY CONTROL


INTERNAL QUALITY CONTROL EXTERNAL QUALITY CONTROL

To monitor and ensure the reliability of test It is a method that allows for comparision of a
results procedure by the laboratory laboratory’s testing to source outside lab.
Done on daily basis Done twice or thrice a month

It is necessary to maintain accuracy and Necessary for long term accuracy of analyte
precision of test results on daily basis method
FACTORS INFLUENCING QUALITY CONTROL
RESULTS
1. PREANALYTICAL ERRORS: Pre-analytical errors can occur before the
sample ever reaches the laboratory but directly affect the quality
and clinical usefulness of the final result.
• Improper preparation of the patient
• Improper collection of blood sample
• Incorrect specimen storage
• Incorrect specimen transport
• Incorrect labelling
• Incorrect test request
2. ANALYTICAL ERRORS: Once the sample arrives in the laboratory a
wide variety of potential analytical errors during the performance of the
test may affect the quality of the results obtained.
• No proper instrument maintainance
• Result request errors
• Calibration errors
• Wrong reagent preparations
• Control is out of range
• Incorrect analytical procedure
• Laboratory personals not trained
• Not following SOP (Standard Operating Procedures)
3. POST ANALYTICAL ERRORS: The prompt and correct delivery of the
correct report on the correct patient to the correct doctor.
• Improper interpretation of reports
• Transcription errors in reporting
• Delay in reporting
• More turn around time
• Giving the report to wrong individuals
• Incorrect dilution
ERRORS OF MEASUREMENT

• It is the discrepancy between the true value and the measured value
• TYPES OF ERROR:
1. SYSTEMATIC ERROR: Avoidable error due to controllable variables in
the measurement .
2. RANDOM ERROR: Unavoidable error that are always present in any
measurement which is impossible to eliminate.
QUALITY CONTROL CHARTS

• These are used to compare the observed control value with control
limits.
• They provide visual display that can be quickly reviewd
• Control charts help us to understand accuracy and precision.
• The value will indicate if the analytical run is in control or out of
control.
• LEVY JENNING CHARTS:
• A graphical method for displaying control results and evaluating
whether the procedure is in or out of control. Control values are plottes
versus time.

• WESTGARD RULES:
• “MULTIRULE QUALITY CONTROL” developed by Dr.James O.Westgard
based on statistical concepts.
• Uses a combination of decision criteria or control rules.
• Allows determination of whether an analytical run is in-control or out-
of-control.
• WESTGARD PROVIDES MULTIPLE QC RULES:
• Defines acceptability
• Minimizes false rejections
• Maintains high false detection and to decide whether it is systematic
or random error.
THANK YOU !

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