Chapter 3 - quality assurance in hematology and hemostasis testing

moving average algorithm

this procedure is NOT employed to validate a new assay

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?

student t-test

statistical test that compares means

precise but not accurate

acceptable hemoglobin control value range is 13±0.4 g/dL

control is assayed 5 times and produces following five results

12.0 g/dL

12.3 g/dL

12.0 g/dL

12.2 g/dL

12.1 g/dL

5,400 - 6,600/uL

WBC count control has a mean value of 6000/uL & SD of 300/uL

what is the 95.5% confidence interval?

analytical specificity

what do you call the ability of an assay to distinguished the targeted analyte from interfering substances within the specimen matrix?

laboratory-developed test

the laboratory purchases reagents from manufacturer and develops assay using a protocol published in a volume of the Methods in Molecular Biology series.

how would the FDA classify this assay?

distribution of proficiency materials to all sites

what process ensures comparability in multisite validation?

establishing the RI by transference

a laboratory scientist measures prothrombin time for plasma aliquots from 15 healthy men and 15 healthy women

the scientist computes the mean and 95.5% confidence interval & notes that they duplicate the manufacturer’s statistics within 5%.

this procedure is known as?

control

you purchased a preserved whole blood specimen from a distributor who provides the mean values for several complete blood count analytes

what is this specimen called?

5

clinical efficacy test results

what is the number of false-negative results?

College of American Pathologists (CAP)

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

American Society for Clinical Laboratory Science (ASCLS)

agency that provides continuing medical laboratory education

preanalytical quality assurance

regular view of blood specimen collection quality is an example of what?

postanalytical quality assurance

review of laboratory report integrity is an example of what?

area under the curve

what parameter assesses the overall efficacy of an assay when performing an ROC analysis?

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?