Module 3 - Quality Assurance and Quality Control in the Clinical Laboratory _ NEUVLE

Square root of the variance.

True negatives / (True negatives + False negatives)

Describes how close a test result is to the true value.

Total imprecision analysis.

Wrong or missing patient identification.

The most frequently occurring value

Qualified personnel, established laboratory policies, laboratory procedure manual, test requisitioning, and preventive maintenance of equipment.

To analyze data in control charts based on statistical methods.

How close results are to one another.

Preanalytical and postanalytical phases.

Preventive maintenance records, temperature charts, and QC charts.

Range using 2 SD on either side of the mean.

Incorrect sample and reagent volume.

20 data points from 20 or more separate testing runs

The precision study.

Perform QC activities, maintain instruments, and keep accurate records.

Error due to chance, varies from sample to sample.

Random error.

95%.

Inappropriate performances before specimens are measured by analyzers.

Range of values that includes 95% of test results for a healthy reference population.

Operator or instrument error.

The spread or variability in a data set

Monitoring and documentation of quality assessment records.

Reject results with more than the permitted amount of error.

Critical value reporting.

Repeatability or reproducibility.

Properly standardized procedures, statistically valid comparisons, use of controls, and proficiency testing programs.

Number of patients with a normal test result who do not have the disease

Specimen is similar to patient’s blood, known concentration of constituent.

Cases with specific disease or condition produce a positive result.

Utilizes fewer resources, reduces costs, enhances productivity, promotes staff morale, and improves the quality of patient care.

Less storage space, ease of inventory, and peer laboratory comparisons.

Difference between target value and assayed value, independent of sample concentration.

To ensure accuracy and precision of test performance over time.

How close the test results are to one another.

To compare results obtained on high and low control serum from different laboratories.

Proportion of a population who has the disease.

By running 2 control solutions twice a day over a 10-to-20-day period.

99.7%.

To detect errors from test system failure, adverse environmental conditions, and variance in operator performance.

Specimen collected in wrong tube.

Acceptable limits of variation in the results of an analytic method.

Greater deviation from target value due to higher sample concentration.

Accuracy in testing.

Consistent bias problems.

Standard deviation (SD) or coefficient of variation (CV).

Proportion of cases with absence of the specific disease that give a negative test result.

Number of patients with an abnormal test result who have the disease.

Internal QC, proficiency testing, accreditation, quality assurance monitoring, and laboratory utilization.

68%.

Anything that does not meet customer requirements.

Per million opportunities (DPMO).

Reducing waste (nonvalued activities).

Material or solution with a known concentration of the analyte.

Error influencing observations consistently in one direction.

A minimum of seven units (three replicates per run)

Patient identification.

A proportional error.

Inclusion of standards, reference samples, control solutions, replicate determinations, and duplicate determinations.

True positives / (True positives + False negatives) x 100.

Number of subjects found to have the disease within a defined period in a population.

Comparison of an instrument measure or reading to a known physical constant.

Normal bell-shaped Gaussian curve

Details of deviation from usual results, problems, failures, and corrective actions.

Review procedure, correct error, and repeat testing.

How close a test result is to the true value.

Process that monitors accuracy and reproducibility of results.

Highly purified substances of a known composition.

Highly purified substance of a known composition.

Comprehensive listing of approved policies, acceptable practices, and precautions.

Cases without a specific disease or condition produce a negative result.

It is a QC chart used in clinical laboratories.

Greater reproducibility between bottles.

Current results with past results of the same analytes on the same individual.

The difference between QC results and the target means.

When the slope exceeds 45° or a decision (±2.7 SD) is exceeded.

True negatives / (False positives + True negatives) x 100.

After the analysis is complete but within the laboratory.

Monitoring performance of laboratory instruments, reagents, other testing products, and equipment.

Unavailable or delayed results, long turnaround time, incomplete results, wrong transcription, missing results, results submitted to the wrong physician.

Process by eliminating variations or errors, improved performance, quality, bottom line, customer satisfaction, and employee satisfaction.

Proportion of cases with a specific disease that give a positive test result.

Error with handwritten labels and request forms.

V mask.

Comparison of an instrument measure to a known physical constant.

To reduce the number of defects to near zero.

Closeness to true or actual value.