Podcast
Questions and Answers
What is the main purpose of proficiency testing in laboratories?
What is the main purpose of proficiency testing in laboratories?
Which of the following characteristics is NOT considered ideal for quality control materials?
Which of the following characteristics is NOT considered ideal for quality control materials?
What is indicated if a laboratory's results differ by greater than 2 standard deviations from the peer mean?
What is indicated if a laboratory's results differ by greater than 2 standard deviations from the peer mean?
Which of the following best describes the rationale behind external quality control?
Which of the following best describes the rationale behind external quality control?
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Why might bovine control materials be used instead of human control materials?
Why might bovine control materials be used instead of human control materials?
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What is the potential consequence if a clinical laboratory fails to resolve a testing error?
What is the potential consequence if a clinical laboratory fails to resolve a testing error?
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What does an assayed control material provide to a clinical laboratory?
What does an assayed control material provide to a clinical laboratory?
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Which factor is critical for ensuring the integrity of quality control materials post-opening?
Which factor is critical for ensuring the integrity of quality control materials post-opening?
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What action is necessary when using quality control materials from different lot numbers?
What action is necessary when using quality control materials from different lot numbers?
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When comparing laboratory results, which statistical factor is utilized to assess performance criteria?
When comparing laboratory results, which statistical factor is utilized to assess performance criteria?
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What is the primary purpose of external quality control (QC) in clinical laboratories?
What is the primary purpose of external quality control (QC) in clinical laboratories?
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Which proficiency program is considered the gold standard for external QC testing in clinical laboratories?
Which proficiency program is considered the gold standard for external QC testing in clinical laboratories?
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What characteristic must proficiency test (PT) samples have in order to be effective?
What characteristic must proficiency test (PT) samples have in order to be effective?
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What is a significant challenge associated with preparing commutable proficiency test samples?
What is a significant challenge associated with preparing commutable proficiency test samples?
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What is the correct conduct of external quality control testing for unknown samples?
What is the correct conduct of external quality control testing for unknown samples?
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How should the results of proficiency testing be reported?
How should the results of proficiency testing be reported?
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What may be a major consequence of not following the external quality control guidelines?
What may be a major consequence of not following the external quality control guidelines?
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Why is it important for unknown samples to be processed like patient specimens during quality control testing?
Why is it important for unknown samples to be processed like patient specimens during quality control testing?
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What is a common practice in preparing proficiency test samples for external QC?
What is a common practice in preparing proficiency test samples for external QC?
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What is a critical time-related requirement for the analysis of unknown samples in external QC?
What is a critical time-related requirement for the analysis of unknown samples in external QC?
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Study Notes
Interlab Quality Control (External QC)
- Proficiency testing programs periodically provide clinical laboratories with samples of unknown concentrations.
- Essential for maintaining the accuracy of analytical methods over time.
- Helps to assess state-of-the-art performance across participating laboratories.
- The College of American Pathologists (CAP) proficiency program is regarded as the gold standard.
Samples for External Quality Control/Proficiency Testing
- Preferred proficiency test (PT) samples should be commutable with patient samples.
- Clinical samples, like serum, are pooled to prepare commutable samples, minimizing additives to maintain original state.
- Commutable PT samples are challenging and costlier to produce than noncommutable samples.
Conduct of External Quality Control Testing
- Unknown samples are sent from a reference laboratory to participating laboratories.
- Samples must be tested by personnel who analyze patient specimens with the same reagents and equipment.
- Testing results must be submitted promptly without sharing amongst participating laboratories during the testing cycle.
- Comparison studies can occur after testing for performance assessment and areas for improvement.
Interpretation of Proficiency Testing Results
- Performance criteria exist for analytes (e.g., ±2 SD from peer mean).
- Deviations greater than 2 SD indicate potential discrepancies in a laboratory’s results.
- Failure to identify discrepancies could result in facility closure recommendations.
Rationale for External Quality Control/Proficiency Testing
- Proficiency testing ensures the accuracy of patient results, providing clinicians with confidence.
- Serves as a continuous improvement tool and a troubleshooting guide for analytical errors.
Quality Control Materials/Control Samples
- QC materials act as surrogates for clinical samples tested daily like patient specimens.
- Available commercially in both liquid and lyophilized forms.
- Can be sourced from equipment/reagent manufacturers or third-party vendors.
Characteristics of an Ideal QC Material
- Resembles human samples with known analyte concentrations.
- Inexpensive, stable for extended periods, and free from communicable diseases.
- Must have convenient packaging for easy dispensing and storage.
Notes to Remember on QC Materials
- QC materials should closely resemble human samples and remain available for at least one year (same lot number).
- Different lot numbers have varied concentrations necessitating new mean and standard deviation estimates.
- Human control materials are preferable; however, bovine materials are common due to availability and safety concerns.
- QC materials must share the same matrix as the specimens being tested (e.g., serum samples for glucose measurements).
- Proper reconstitution of lyophilized materials is crucial to avoid incorrect control values.
- Deterioration of QC materials can occur post-opening due to mishandling; re-evaluate with fresh containers if issues arise.
- Assayed controls, while pricier, offer external accuracy checks and are standard in internal QC practices.
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Description
Test your knowledge on external quality control in clinical laboratories. This quiz covers proficiency testing programs, the importance of accuracy in analytical methods, and the standards set by the College of American Pathologists. Join to learn more about interlaboratory performance and quality assurance.