Laboratory Quality Management Flashcards
(52 cards)
What is the primary goal of quality management in clinical chemistry?
To ensure accurate and reliable laboratory test results for patient care.
True or False: Quality management in clinical chemistry involves monitoring and improving all aspects of the testing process.
True
What is the purpose of internal quality control in clinical chemistry?
To monitor the precision and accuracy of test results within the laboratory.
Fill in the blank: External quality assurance programs involve sending samples to an __________ laboratory for evaluation.
independent
What does the term ‘total quality management’ refer to in clinical chemistry?
An approach that involves continuous improvement of all processes in the laboratory.
Which regulatory body oversees quality management in clinical chemistry laboratories in the United States?
The Centers for Medicare and Medicaid Services (CMS)
What is the purpose of establishing reference intervals in clinical chemistry?
To determine the normal range of values for a particular analyte in a specific population.
What is the term used to describe the process of comparing test results from different methods or instruments?
Method comparison
True or False: Quality control materials should be run at the beginning and end of each testing batch.
True
What is the role of the clinical chemist in quality management?
To oversee the implementation and maintenance of quality control procedures in the laboratory.
What is the purpose of proficiency testing in clinical chemistry?
To evaluate the laboratory’s performance by comparing results with other laboratories.
Which statistical tool is commonly used to assess the precision of a laboratory test?
Coefficient of variation (CV)
Fill in the blank: The acronym IQCP stands for _______ Quality Control Plan.
Individualized
What is the main advantage of using automated analyzers in clinical chemistry?
Increased efficiency and reduced human error.
True or False: Quality management in clinical chemistry is only important for large laboratory facilities.
False
What is the purpose of traceability in laboratory testing?
To ensure that test results can be linked back to a recognized standard.
Which type of error occurs when a laboratory test result is higher or lower than the true value?
Systematic error
What does the term ‘bias’ refer to in clinical chemistry?
A consistent deviation of test results from the true value.
True or False: Quality management systems in clinical chemistry must comply with regulatory requirements.
True
What is the purpose of conducting risk assessments in quality management?
To identify potential sources of error and develop strategies to mitigate them.
Fill in the blank: The acronym CAPA stands for Corrective and _______ Action.
Preventive
What role does documentation play in quality management in clinical chemistry?
It provides evidence of compliance with quality standards and regulatory requirements.
True or False: Quality management in clinical chemistry is a one-time process that does not require ongoing monitoring.
False
What is the purpose of conducting a root cause analysis in quality management?
To identify the underlying cause of a quality issue and implement corrective actions.
