Quality Control

49問 • 2年前

問題一覧

An all-inclusive / comprehensive system monitoring the accuracy of test results where all steps before, during and after the testing process are considered.

Quality Assurance/Assessment (QA)

Quality Assurance/Assessment (QA) includes the what factors?

Pre-Analytic factors, Analytic Factors, Post Analytic Factors

It includes commitment to quality, facilities, resources, competent staff, and reliable procedures, methods and instrumentation

Essentials

Provides a structure for achieving lab and hospital quality goals.

Quality Assurance/Assessment (QA)

It is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results and improve the quality of the results reported by the laboratory.

Laboratory quality control

It is a measure of precision or how well the measurement system reproduces the same result over time and under varying operating conditions.

Quality control

It is usually run at the beginning of each shift; after an instrument is serviced; when reagent lots are changed; after calibration, and when patient results seem inappropriate.

Laboratory quality control material

What are the types of Quality Control?

Internal, External

What type of Quality Control is the ff under: -Daily Establishment of reference ranges -Validation of a new reagent lot and/or shipment -Following instrument repair

Internal

What type of Quality Control are the ff under: -Determination of laboratory testing performance by means of intralaboratory comparisons -CAP, CLIA, The Joint Commission requirement

External

What are the measures of Central Tendency?

Mean, Median, Mode

It is a (science of )branch of mathematics that collects, analyzes, summarizes and presents information about “observations.”

Statistics

What are the Post-Analytical Causes of Error?

Incorrect reference values, Physician not notified of a panic or critical value, Incorrect interpretation of lab result by physician, Incorrect data entry of lab result

It can help us to define Reference ranges for patient’s (normal and abnormal) Acceptable ranges for control specimens ( “in” and “out” of control)

A statistical analysis of lab test data

the mathematical average of a group of numbers, determined by adding a group of numbers (events) and dividing the result by the number of events.

Mean

determined as the ‘middle’ of a group of numbers that have been arranged in sequential order. That is to say, there are an equal number of numbers on either side of the ‘middle’ number. In an odd # of observations, it is the middle observation. In an even # of observations, average the two middle values.

Median

the number that appears most frequently in a group of numbers. There can be more than mode, or none at all.

Mode

It refers to the ability to get the same (but not necessarily ‘true’) result time after time.

Precision

It is one that is the true result

Accurate Result

Systematic change in the test system resulting in a displacement of the mean from the original value

Systematic Error

What are the causes of Systematic Error?

-Change in reagent or calibrator lot numbers -Wrong calibrator values -Improperly prepared reagents -Deterioration of reagents or calibrators -Inappropriate storage of reagents or calibrators -Variation in sample or reagent volumes due to pipettor misalignments -Variation in temperature or reaction chambers -Deterioration of photometric light source -Variation in procedure between technologists

Imprecision of the test system causing a scatter or spread of control values around the mean

Random error

What are the causes of Random Error?

-Air bubbles in reagent -Improperly mixed reagents -Reagent lines, sampling, or reagent syringes -Improperly fitting pipette tips -Clogged or imprecise pipetter -Fluctuations in power supply

It is the amount by which an analysis varies from the correct result.

Bias

AMR stands for

Analytical Measurement Range

CRR stands for

Clinical Reportable Range

Range of analyte values that a method can directly measure on the specimen without any dilution, concentration or other pretreatment

Analytical Measurement Range (AMR)

Range of analyte values that a method can report as a quantitative result, allowing for specimen dilution, concentration, or other pretreatment used to expand the direct AMR.

Clinical Reportable Range (CRR)

It is a material or preparation used to monitor the stability of the test system within predetermined limits

Control

Its main purpose is to verify the analytic measurement range of instrument for a specific analyte.

Measure of precision and reproducibility

Types of Control Material Matrix

Lyophilized/liquid, Assayed, Unassayed

In this type off Control material matrix, Mean is calculated by the manufacturer and must be verified in the laboratory.

Assayed

This type of control material matrix is less expensive and must perform the data analysis at home.

Unassayed

It is a graph that plots QC values in terms of how many standard deviations each value is from the mean.

Levey Jennings chart

Control chart is also known as what?

Shewhart chart or process behavior chart

It is a statistical tool intended to assess the nature of variation in a process and to facilitate forecasting and management.

Control chart

It is a graphical presentation used in interpreting quality control data

Levey-Jennings chart

It means that there is too much dispersion in your result compared with the rest of the results.

Out of control

It can be applied to see whether the results from the samples when the control was done can be released, or if they need to be rerun.

Westgard rules

They are used to define specific performance limits for a particular assay and can be used to detect both random and systematic errors. And they are programmed into automated analyzers to determine when an analytical run should be rejected.

Westgard rules

For how long is QC data results distributed on one side of the mean?

6-7 days

Consistent increase or decrease of QC data points over a period of 6-7 days

Trend

QC data results are distributed on one side of the mean for 6-7 consecutive days

Shift

What is the corrective action for Instrument Malfunction?

Identify malfunction and fix

What is the corrective action for Reagents: preparation, contamination, volume

New reagents

What is the corrective action for Tech error?

Identify error and repeat test

What is the corrective action if control specimen is old or prepared improperly

Use new control

It is the comparison of individual patient results throughout the day or week with computer detection of changes from earlier individual patient results.

Delta check

Delta check is helful in identifying what type of error?

Pre-analytical error

Translation(Pre-finals)

MAHATHIR ALPHA · 55問 · 2年前

Translation(Pre-finals)