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Biochemistry Clinical practiceCLS 432
Dr. Samah Kotb Lecturer of Biochemistry
2015
Introduction to Quality Control
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Chapter 3
Introduction to Quality Control
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At the end of this module, participants should be able to:
Define quality control and describe its relationship to the overall quality management system.
Describe differences in quantitative, qualitative, and semi-quantitative examinations.
Learning Objectives
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Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process that produces patient results.
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What is Quality Control?
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Quality control refers to the measures that must be included during each assay run to verify that the test is working properly.
What is Quality Control?
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QC is examining “control” materials of known substances along with patient samples to monitor the accuracy and precision of the complete examination (analytic) process.
Quality Control
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Introduction to Quality Control-Module 6 7
The goal of QC is to detect errors and correct them before patients’ results are reported.
Purpose of QC
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Kinds of quality control
• Quality control is two kinds: a) Internal quality control, the procedure making use of
results of only one laboratory for quality control.
b) External quality control: in which the results of several laboratories which analyze the same sample(s) are used.
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Outside laboratoryOutside laboratory
Within laboratoryWithin laboratory
Samplehandling
Patientpreparation
Requisition
SamplereceivingSample
Collection
SampleTransport
PatientDoctor
Analysis
Reports
Results
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Factors influencing internal quality
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When a Diagnostic test is performed in the medical laboratory, the outcome of the test is a result. The result may be a patient result or it may be a quality control (QC) result.
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The result may be quantitative (a number) or qualitative (positive or negative) or semi-quantitative (limited to a few different values).
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Measure the quantity of a particular substance in a sample
Quantitative Examinations
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Examinations that do not have numerical results:
growth or no growth
positive or negative
reactive or non-reactive
color change
Qualitative Examinations
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Results are expressed as an estimate of the measured substance:
• “trace amount”, “moderate amount,” or “1+, 2+, or 3+”
• number of cells per microscopic field. • Titres and dilutions in serologic tests.
Semi-quantitative Examination Methods
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Two major types of errors may occur in a laboratory:1-Random errors that arise due to inadequate
control on pre-analytical variables, patient identity, sample labeling, sample collection, handling and transport, measuring devices etc.
2- Systemic errors that occur due to inadequate control on analytical variables; e.g. due to error in calibration, impure calibration material, unstable/ deteriorated calibrators, unstable reagent blanks etc.
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Types of Errors
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AccuracyHow well a measurement agrees with an accepted value
PrecisionHow well a series of measurements agree with each other
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Accuracy vs. Precision
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• The degree of fluctuation in the measurements is indicative of the “precision” of the assay.
• The closeness of measurements to the true value is indicative of the “accuracy” of the assay.
• Quality Control is used to monitor both the precision and the accuracy of the assay in order to provide reliable results.
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Accuracy vs. Precision
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Accuracy vs. Precision
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Data Quality Control
• Quality Assurance– Activities to ensure
quality of data before data collection.
• Quality Control– Monitoring and
maintaining the quality of data during the conduct of the study.
• Data Management Handling and processing of data throughout the study.
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• Data and Lab Management• Safety
• Customer Service
Patient/Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Record Keeping
ReportingPersonnel CompetencyTest Evaluations
Testing
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The Quality Assurance CycleQUALITY PROCESS
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1) Specimen
2) Collection technique
3)Storage and transportation
4) Quantity
5) Labeling
6) Mismatch of sample21
Factors influencing quality: Pre-analytical
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EQUIPMENT RELIABILITY
REAGENTS STABILITY, INTEGRITY AND
EFFICIENCY
SPECIFICITY & SENSITIVITY OF SELECTED TEST
PROFICIENCY OF PERSONNEL: Education, Training,
USE OF APPROPRIATE CONTROLS
DOCUMENTATION
ANALYTICAL FACTORS
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Factors influencing quality: Analytical
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Steps in Quality Assurance
1) Specify the study hypothesis.
2) Specify general design to test study hypothesis Develop an overall study protocol.
3) Choose or prepare specific instruments.
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Steps in Quality Assurance
4) Develop procedures for data collection and processing Develop operation manuals.
5) Train staff Certify staff.
6) User certified staff, pretest and pilot-study data collection and processing instruments and procedures.
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Quality Assurance: Training of Staff
• Aim to make each staff person thoroughly familiar with procedures under his/her responsibility.
• Training certification of the staff member to perform a specific procedure.
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Quality Assurance: Pretesting and Pilot testing
• Pretesting– Involves assessing
specific procedures on a sample in order to detect major flaws.
• Pilot Testing– Formal rehearsal of
study procedures.
– Attempts to reproduce the whole flow of operations in a sample as similar as possible to study participants.
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If you have not documented it, you have NOT done it
…
If you have not documented, it is a RUMOUR !!!
Documentation
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Data Management: Handling of Data
• Entering data
– Use professional data entry program like EpiData
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Backing up vs Archiving
• Backing up– Everyday activity.
– Purpose to able you to restore your data and documents in case of destruction or loss of data.
– Not only datasets, but also command files modifying your data, written documents such as the protocol, log book and other documenting information.
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Archiving
• Archiving– Takes place once or a few times during the life of the
project.
– Purpose is to preserve your data and documents for a more distant future, maybe to even allow other researchers access to the information.
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• Important part of quality management system.
• Goal is to identify errors and eliminate them before reporting patient results.
• Different methods applied for quantitative, qualitative, and semi-quantitative results
QC Summary
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