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CLINICAL CHEMISTRY > Laboratory Quality Management > Flashcards

Laboratory Quality Management Flashcards

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1
Q

What is the primary goal of quality management in clinical chemistry?

A

To ensure accurate and reliable laboratory test results for patient care.

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2
Q

True or False: Quality management in clinical chemistry involves monitoring and improving all aspects of the testing process.

A

True

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3
Q

What is the purpose of internal quality control in clinical chemistry?

A

To monitor the precision and accuracy of test results within the laboratory.

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4
Q

Fill in the blank: External quality assurance programs involve sending samples to an __________ laboratory for evaluation.

A

independent

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5
Q

What does the term ‘total quality management’ refer to in clinical chemistry?

A

An approach that involves continuous improvement of all processes in the laboratory.

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6
Q

Which regulatory body oversees quality management in clinical chemistry laboratories in the United States?

A

The Centers for Medicare and Medicaid Services (CMS)

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7
Q

What is the purpose of establishing reference intervals in clinical chemistry?

A

To determine the normal range of values for a particular analyte in a specific population.

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8
Q

What is the term used to describe the process of comparing test results from different methods or instruments?

A

Method comparison

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9
Q

True or False: Quality control materials should be run at the beginning and end of each testing batch.

A

True

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10
Q

What is the role of the clinical chemist in quality management?

A

To oversee the implementation and maintenance of quality control procedures in the laboratory.

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11
Q

What is the purpose of proficiency testing in clinical chemistry?

A

To evaluate the laboratory’s performance by comparing results with other laboratories.

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12
Q

Which statistical tool is commonly used to assess the precision of a laboratory test?

A

Coefficient of variation (CV)

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13
Q

Fill in the blank: The acronym IQCP stands for _______ Quality Control Plan.

A

Individualized

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14
Q

What is the main advantage of using automated analyzers in clinical chemistry?

A

Increased efficiency and reduced human error.

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15
Q

True or False: Quality management in clinical chemistry is only important for large laboratory facilities.

A

False

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16
Q

What is the purpose of traceability in laboratory testing?

A

To ensure that test results can be linked back to a recognized standard.

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17
Q

Which type of error occurs when a laboratory test result is higher or lower than the true value?

A

Systematic error

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18
Q

What does the term ‘bias’ refer to in clinical chemistry?

A

A consistent deviation of test results from the true value.

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19
Q

True or False: Quality management systems in clinical chemistry must comply with regulatory requirements.

A

True

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20
Q

What is the purpose of conducting risk assessments in quality management?

A

To identify potential sources of error and develop strategies to mitigate them.

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21
Q

Fill in the blank: The acronym CAPA stands for Corrective and _______ Action.

A

Preventive

22
Q

What role does documentation play in quality management in clinical chemistry?

A

It provides evidence of compliance with quality standards and regulatory requirements.

23
Q

True or False: Quality management in clinical chemistry is a one-time process that does not require ongoing monitoring.

A

False

24
Q

What is the purpose of conducting a root cause analysis in quality management?

A

To identify the underlying cause of a quality issue and implement corrective actions.

25
Q

Which organization is responsible for accrediting clinical laboratories in the United States?

A

The College of American Pathologists (CAP)

26
Q

What is the term used to describe the ability of a test to detect small differences in analyte concentration?

A

Analytical sensitivity

27
Q

Fill in the blank: The acronym CLIA stands for Clinical Laboratory Improvement ________ Act.

A

Amendments

28
Q

What is the purpose of establishing quality indicators in clinical chemistry?

A

To monitor and evaluate the performance of the laboratory over time.

29
Q

True or False: Quality management in clinical chemistry does not involve the use of technology or automation.

A

False

30
Q

What is the role of the quality assurance manager in clinical chemistry?

A

To oversee the overall quality management program and ensure compliance with regulations.

31
Q

What is the primary focus of a laboratory audit in quality management?

A

To assess the laboratory’s compliance with quality standards and identify areas for improvement.

32
Q

Which organization publishes guidelines for laboratory quality management systems?

A

The International Organization for Standardization (ISO)

33
Q

Fill in the blank: The acronym EQA stands for External Quality ________.

A

Assessment

34
Q

What is the purpose of conducting a method validation study in clinical chemistry?

A

To assess the performance characteristics of a new test method before implementation.

35
Q

True or False: Quality management in clinical chemistry does not require ongoing training and education for laboratory staff.

A

False

36
Q

What is the term used to describe the ability of a test to provide consistent results over time?

A

Analytical precision

37
Q

What is the purpose of establishing critical values in clinical chemistry?

A

To identify results that require immediate clinical attention and notification.

38
Q

Which type of quality control material is used to monitor the entire testing process from pre-analytical to post-analytical phases?

A

Multi-rule control material

39
Q

Fill in the blank: The term ‘post-analytical phase’ refers to the process of ________ test results after analysis is complete.

A

interpreting

40
Q

What is the main purpose of implementing a quality management system in clinical chemistry?

A

To ensure the reliability and accuracy of laboratory test results for patient care.

41
Q

True or False: Quality management in clinical chemistry is primarily focused on cost reduction.

A

False

42
Q

What is the term used to describe the process of evaluating the accuracy of a test method by comparing results to a known standard?

A

Calibration

43
Q

What is the role of the quality control coordinator in clinical chemistry?

A

To manage the daily implementation of quality control procedures and troubleshoot issues.

44
Q

Which type of quality control material is used to monitor the precision of a test method?

A

Single-rule control material

45
Q

Fill in the blank: The term ‘pre-analytical phase’ refers to the process of ________ specimens before analysis.

A

handling

46
Q

What is the primary purpose of conducting an internal audit in quality management?

A

To assess the laboratory’s compliance with quality standards and identify areas for improvement.

47
Q

True or False: Quality management in clinical chemistry is not essential for ensuring patient safety.

A

False

48
Q

What is the term used to describe the process of comparing test results from different instruments or methods?

A

Inter-laboratory comparison

49
Q

What is the purpose of conducting a risk management assessment in quality management?

A

To identify potential sources of error and develop strategies to mitigate them.

50
Q

Which regulatory agency oversees the certification of medical laboratories in the United States?

A

The Clinical Laboratory Improvement Amendments (CLIA)

51
Q

Fill in the blank: The term ‘analytical phase’ refers to the process of ________ specimens in the laboratory.

A

analyzing

52
Q

What is the main goal of conducting a quality improvement project in clinical chemistry?

A

To identify areas for improvement and implement changes to enhance the quality of laboratory services.

CLINICAL CHEMISTRY (1 decks)

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