Quality Assurance in Hematology

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Quality Assurance

Refers to the over-all process of guaranteeing quality patient care.

Quality Assurance

This is a continual monitoring of the entire test process from test ordering, specimen collection, processing, reporting, and interpretation of the results.

Quality Assurance

This is a continual monitoring of the entire test process from test ordering, specimen collection, processing, reporting, and interpretation of the results.

d. Moving average algorithm

What procedure is NOT employed to validate a new assay?

a.     Comparison of assay results to a reference method

b.     Test for assay precision

c.      Test for assay linearity

d.     Moving average algorithm

Constant systematic error

You validate a new assay using linear regression to compare assay calibrator results with the distributor’s published calibrator results. The slope is 0.99 and the y intercept is 10%. What type of error is present?

b. Student t-test

Which is a statistical test that compares means?

a.     Bland-Altman

b.     Student t-test

c.      ANOVA

d.     Pearson

b. Precise but not accurate

The acceptable hemoglobin control value range is 13 0.4 g/dL. The control is assayed five times and produces the following five results:

12.0 g/dL 12.3 g/dL 12.0 g/dL 12.2 g/dL 12.1 g/dL

These results are:

a.     Accurate but not precise

b.     Precise but not accurate

c.      Both accurate and precise

d.     Neither accurate nor precise

b. 5400 to 6600/ L

A WBC count control has a mean value of 6000/ L and an SD of 300/ L. What is the 95.5% confidence interval?

a.     3000 to 9000/ L

b.     5400 to 6600/ L

c.     5500 to 6500/ L

d.     5700 to 6300/ L

Analytical specificity

The ability of an assay to distinguish the targeted analyte from interfering substances within the specimen matrix is called:

a.     Cleared

b.     Research use only

c.     Analyte-specific reagent

d.     Laboratory-developed test

The laboratory purchases reagents from a manufacturer and develops an assay using a protocol published in a volume of the Methods in Molecular Biology series. How would the FDA classify this assay?

a. Distribution of proficiency materials to all sites

What process ensures comparability in multi-site validation?

a.     Distribution of proficiency materials to all sites

b.     Publication of individual site reference intervals

c.      Clinical sensitivity and specificity computations

d.     ROC analysis

d.     Establishing the RI by transference

A laboratory scientist measures prothrombin time for plasma aliquots from 15 healthy men and 15 healthy women. She computes the mean and 95.5% confidence interval and notes that they duplicate the manufacturer’s statistics within 5%. This procedure is known as:

a.     Setting the RI

b.     Confirming linearity

c.      Determining the therapeutic range

d.     Establishing the RI by transference

Control

You purchase a preserved whole blood specimen from a distributor who provides the mean values for several complete blood count analytes. What is this specimen called?

c. College of American Pathologists (CAP)

What agency provides external quality assurance (proficiency) surveys and laboratory accreditation?

a.     Clinical Laboratory Improvement Advisory Committee(CLIAC)

b.     Centers for Medicare and Medicaid Services (CMS)

c.      College of American Pathologists (CAP)

d.     The Joint Commission

b. American Society for Clinical Laboratory Science (ASCLS)

What agency provides continuing medical laboratory education?

a.     Clinical Laboratory Improvement Advisory Committee (CLIAC)

b.     American Society for Clinical Laboratory Science (ASCLS)

c.      Centers for Medicare and Medicaid Services (CMS)

d.     College of American Pathologists (CAP)

b.     Preanalytical quality assurance

Regular review of blood specimen collection quality is an example of:

a.     Postanalytical quality assurance

b.     Preanalytical quality assurance

c.      Analytical quality control

d.     External quality assurance

Preanalytical quality assurance

Review of laboratory report integrity is an example of:

a. Area under the curve

When performing a receiver operating curve analysis, what parameter assesses the overall efficacy of an assay?

a.     Area under the curve

b.     Performance limit (threshold)

c.     Positive predictive value

d.     Negative predictive value

b. Proficiency testing

You require your laboratory staff to annually perform manual lupus anticoagulant profiles on a set of plasmas with known values. This exercise is known as:

a.     Assay validation

b.     Proficiency testing

c.     External quality assessment

d.     Pre-pre analytical variable assay