Module 12: Quality Control
The Lab Quality System
Organizat ion Personnel
Equipme nt
Purchasin g& Inventory
Process Control Quality Control & Specimen Managemen t
Informatio n Managem ent
Assessme nt
Documen ts & Records
Process Improveme nt
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Occurren ce Managem ent Customer Service
Facilities & Safety
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Learning Objectives
At the end of this module, you will be able to: Differentiate between internal and external controls Use external quality controls at designated frequencies Analyze common problems associated with invalid test results
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Content Overview
What is Quality Control (QC)? Benefits of QC in rapid testing Internal versus external quality control Troubleshooting invalid results Quality control records
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What Is Quality Control (QC)?
Measures taken to monitor the quality of the
test itself QC for HIV Rapid Testing includes:
Testing of samples with known results to verify if the procedure is working properly Interpreting the presence or absence of control bands/lines within the device itself
If an error occurs, do not release or report
results until you have corrected the error.
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Sources of Controls
Internal to the test Kit
Control samples provided with the test kit with known reactivity Region within the device, also termed procedural or in-built control Control samples not included with the test kit provided an external source that has been validated for use with a specific test kit
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External to the test Kit
Internal and External Quality Control
Internal Control Included in testing device or as part of the kit External Control Known positive and negative samples that are used to validate the reliability of the test system
Control Band
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Examples of Tests that Include Internal Control
Capillus Determine Hema-Strip OraQuick Uni-Gold
Which test does not have internal control built into its device?
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Capillus Kit Comes with Internal Control Samples
Positive and Negative Control Samples
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Sources of External Quality Control Samples
Prepared by Reference Laboratory
Store according to
Commercially prepared
instructions Date when opened Use before expiry date Do not contaminate
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Frequency of Use: When Should You Test External Control Samples?
Minimum once a week, beginning of the week New shipment of test kits Beginning a new lot number Environmental conditions exceed range needed for stability of kits
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Invalid Results What Do You Do?
Repeat test If repeatedly invalid:
assume problem with test product or procedure continue with alternative testing algorithm
Identify cause of problem Inform supervisor Take corrective actions
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Problem
Troubleshooting Invalid Results
Potential Cause Damaged test device
or controls Proper procedure not followed
Action
No control line or band present
Repeat the test using new device and blood sample Follow each step of testing according to SOP Re-check buffer and/or specimen volumes Wait for the specified time before reading the test Check expiration date of kits or controls. Do not use beyond stated expiration date Check temperature records for storage and testing area
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Expired or improperly stored test kits or controls
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Troubleshooting Invalid Results Contd Contd
Problem
Positive reaction with negative external control, i.e. false positive Extremely faint control line Incubation time exceeded
Potential Cause
Action
Re-test negative control using a new device and read results within specified time limit
The control line can vary in intensity
No action required. Any visible line validates the results.
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Possible HIV Test Outcomes: Parallel Algorithm TEST 1 TEST 2 TEST 3
Non-reactive Reactive Non-reactive Reactive Non-reactive Reactive Non-reactive Reactive Reactive Non-reactive Reactive Non-reactive Non-reactive Non-reactive Reactive Reactive
HIV Status
Negative Positive Negative Negative Positive Positive
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Exercise #1: Interpreting Rapid Test Results
Refer to the handout in your participant
manual Read the test results and write your interpretation in the space provided.
Time: 3 minutes
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Exercise #2: Resolving Unreportable Test Results Uni-gold
Determine Uni-gold
Hemastrip
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If not,
Exercise #2: Resolving Unreportable Test Results results? Contd Contd Should you accept the
What should be your next steps? What might have caused the tiebreaker test to yield an invalid result? What corrective actions might you take?
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Maintaining Quality Control Records
WHY?
Troubleshooting Provides proof reliable test results
HOW?
Use standard worksheets
WHEN?
Each time QC materials are tested Record all invalid results and inform supervisor
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Quality Control Record: An Example
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Periodic Review of Records
Review of internal control results before
accepting test results Review of external control results by test performer Weekly or monthly review of external quality control results by testing site supervisor Periodic audits or assessments
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Summary
What is quality control? What is an internal quality control? What is an external quality control? How often and when should external controls be used?
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Summary Contd Contd
What would you do if your external control
tested invalid? Give examples of problems encountered with QC results, why they occurred, and how to correct them. Why is it important to maintain records of QC results?
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