analytical process control bernard - 11.07.12
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ANALYTICAL PROCESS ANALYTICAL PROCESS CONTROLCONTROL
QC FOR QUALITATIVE TESTS
Dr. Bernard Natukunda
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INTERNAL QUALITY CONTROL INTERNAL QUALITY CONTROL (IQC)(IQC)
IQC REFERS TO THE SET OF PROCEDURES UNDERTAKEN BY THE LABORATORY
STAFF FOR THE
CONTINUOUS AND IMMEDIATE
MONITORING OF LABORATORY WORK IN ORDER TO DECIDE WHETHER THE
RESULTS ARE RELIABLE ENOUGH TO BE RELEASED.
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What is IQC?What is IQC?
• The regular testing of quality control [QC] material along with the patient samples
• Comparison of the QC results to specific statistical limits [ranges]
• Rejection of patient results if QC is outside of limits
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WHAT IS THE MOST COMMON WHAT IS THE MOST COMMON LABORATORY ERROR?LABORATORY ERROR?
TRANSCRIPTION
Not technical
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Specimen
• Appropriate specimen
• Collection method
• Delivery system
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PPTC, Wellington, NZ
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IDENTIFICATION SYSTEMIDENTIFICATION SYSTEM
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QC of Stains and Reagents
Proper stains
Reagents
Temperature chart: Incubator
Refirgerator storage: daily temp monitoring
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PPTC, Wellington, NZ
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PPTC, Wellington, NZ
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Sources of Error
• If you encounter an unusual pattern– rule out error by checking – repeat the test
• Report if repeat testing yields same result, or refer to a reference laboratory for confirmation
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QC in Blood Transfusion Service
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Donors Recipients
Safety Precautions
Recruit – Screen – Bleed test – process – Xmatch transfuse – follow up
Blood Transfusion ServiceBlood Bank
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QC in Blood Bank Technology
• Donor services
• Blood grouping
• Cross-match & antibody screening
• Transfusion
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QC in Blood Bank
• Positive and negative controls on all tests
• Reverse grouping
• Good documentation, SOPs etc
• Equipment monitoring, calibration, maintenance
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QC of Rapid Tests for Infectious Diseases
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Infectious Diseases Serology QC of Rapid Methods
• IQC• Positive controls• Negative controls
» How often?» Where do you get the controls from?
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Qualitative versus Quantitative
• Quantitative test – measures the amount of a substance present
• Qualitative test– determines whether the substance being tested
for is present or absent
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What is Quality Control?
• Process or system for monitoring the quality of laboratory testing, and the accuracy and precision of results
• Routinely collect and analyze data from every test run or procedure
• Allows for immediate corrective action
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Designing a QC Program
• Establish written policies and procedures– Corrective action procedures
• Train all staff
• Design forms
• Assure complete documentation and review
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MURAKOZE CYANE