Quality Control & Assurance Flashcards
9 cards from real CMLA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 9 Quality Control & Assurance flashcards as text
What is the main purpose of quality control (QC) in the laboratory?
Answer: Ensure test accuracy
Quality control (QC) in the laboratory is a system of checks and procedures designed to monitor the analytical process and ensure the reliability and accuracy of test results. By running control samples with known values, QC helps identify and correct any issues that could affect patient diagnoses and treatment.
Which of the following is an example of external quality assessment?
Answer: Proficiency testing
Proficiency testing (PT), also known as external quality assessment (EQA), involves laboratories analyzing unknown samples provided by an external organization and comparing their results to those of other labs. This process independently verifies a lab's testing accuracy and helps identify areas for improvement, ensuring consistent quality across different facilities.
What is the purpose of using control samples in testing?
Answer: Verify test accuracy
Control samples are materials with known values that are run alongside patient samples during testing. Their primary purpose is to verify the accuracy and precision of the analytical method and instrumentation. If the control samples yield expected results, it indicates that the test system is functioning correctly.
Which document outlines step-by-step procedures in a lab?
Answer: Standard Operating Procedure
A Standard Operating Procedure (SOP) is a detailed, step-by-step instruction set that guides laboratory personnel through specific tasks or processes. Its purpose is to ensure consistency, safety, and quality in all lab operations. Following SOPs helps maintain accuracy, comply with regulations, and minimize errors.
When should quality control samples be run?
Answer: With every test run
Quality control (QC) samples should be run with every test run to ensure the accuracy and reliability of the testing system. This practice allows for immediate detection of any instrument malfunction or reagent degradation. Running QC samples frequently helps maintain the integrity of patient results and ensures that the testing process is performing within acceptable limits.
Which of the following is a sign of a quality control failure?
Answer: Results out of range
Results out of range for quality control samples are a clear sign of a quality control failure. This indicates that the analytical system is not performing correctly and patient results obtained during that period may be inaccurate. When QC results are out of range, corrective actions must be taken before further patient testing can proceed.
Who is responsible for implementing quality assurance in the laboratory?
Answer: All laboratory staff
Implementing quality assurance in the laboratory is a collective responsibility that involves all laboratory staff, not just managers or technicians. Every individual plays a crucial role in adhering to protocols, documenting procedures, and identifying potential issues. This shared accountability ensures that the laboratory consistently meets high standards for accuracy, reliability, and patient safety.
Why is documentation important in quality assurance?
Answer: To ensure traceability
Documentation is vital in quality assurance to ensure traceability, meaning that every step of a process can be tracked and verified. This allows for investigation of errors, demonstration of compliance with regulations, and continuous improvement of laboratory processes. Proper documentation provides a clear historical record, which is essential for audits, accreditation, and maintaining high standards of quality.
What is a quality audit?
Answer: Process and document review
A quality audit is a systematic and independent examination that involves reviewing processes and documents to determine if quality activities comply with planned arrangements. Its purpose is to evaluate the effectiveness of the quality management system and identify areas for improvement. This ensures that the laboratory consistently meets established standards and regulatory requirements.