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Quality Assurance and Laboratory Mathematics > Quality Assessment > Flashcards

Quality Assessment Flashcards

1
Q

Quality Assurance

A

the entire process starting from the physician ordering lab tests, until they receive the lab results, that ensures the reliability of the test results

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2
Q

Quality Control

A

the process of monitoring the actual testing phase in the laboratory where known and unknown control samples are tested, and the results compared to actual “true” values

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3
Q

Quality Systems

A

a comprehensive program in which all areas of operation are monitored to ensure quality with the aim of providing the highest quality patient care

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4
Q

Quality assessment programs are required by

A

Clinical Laboratory Improvement Act ‘88

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5
Q

What is the purpose of the Quality Assessment Programs?

A
  • To ensure reliable test results
  • improve patient care
  • provide health care that is safe, effective, timely and patient centered
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6
Q

It is important to run _______________ before performing any

A

external controls

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7
Q

confidence limit

A

the upper and lower limits of values that are acceptable when control is analyzed, two standard deviation limit +-2, 95%

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8
Q

outliner

A

the control value falling outside the confidence limit

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9
Q

reference range (normal range)

A

the upper and lower limits within which test results from a normal population would be expected to fall

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10
Q

reportable range (linear range)

A

range of values defining the limits of reliability and accuracy of a particular test method

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11
Q

Levey-Jennings charts

A

the most common chart used to record data for QC

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12
Q

Trend

A

an indication of error in the analysis, detected by a progressive drift of control values in one direction for at least 5 consecutive runs.

-when the QC values gradually move up or down from the mean and continue moving the same direction over time

–can be caused by a calibration that is failing or reagent stability issues

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13
Q

shift

A

-sudden abrupt change from the established mean indicated by the occurrence of all control values on one side of the mean.

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14
Q

Main components of A Quality Systems Control

A
  • Personnel qualifications, training and competency
  • Quality assessment components including preanalytical factors, analytical factors and QC methods, postanalytical factors
  • proficiency testing
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15
Q

Preanalytical Factors that can affect test outcome: (5)

A
  • patient id procedure
  • selecting appropriate specimen and specimen collection method
  • specimen collection technique
  • specimen labeling and transport
  • handling and processing of specimen at testing site
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16
Q

Methods to prevent preanalytical errors include: (5)

A
  • using two patient identifiers
  • maintaining an up-to-date specimen collection manual
  • using correct specimen selection, collection and handling techniques
  • establishing and following specimen rejection criteria
  • maintaining ancillary equipment such as specimen fridges and etc.
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17
Q

postanalytical errors primarily occur in the _________ and ______________ of test results

A

reporting, charting

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18
Q

Analytical Factors affecting laboratory test results: (5)

A
  • instrument maintenance and calibration
  • use of standards and procedural controls
  • techniques and test components associated with performing the test procedure (reagents, lab water, pipetting, timing)
  • interfering substances or conditions
  • statistical analysis of control results
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19
Q

Proficiency Testing

A

another component of lab quality programs.

  • laboratories that perform nonwaived procedures are required to subscribe to an external PT program.
  • at regular intervals a PT agency sends blind samples to the labs, the lab sends the results to the PT agency and the PT agency compares the results to the agency’s assayed results and peer laboratories.

The laboratory then receives a report evaluating their performance.

20
Q

Controls

A

-commercially available assayed solutions that are chemically and physically similar to the unknown and are tested in the same manner as the unknown to monitor the precision of a test method

21
Q

For nonwaived tests, at least _______________must be used, and these must be run a minimum of once each day.

A

two levels of controls

22
Q

The frequency and types of controls required for each analytical procedure will be specified in __________________.

A

Standard Operating Procedure (SOP) manual

23
Q

Levey-Jennings chart

A

a quality control chart used to record daily quality control values

24
Q

Internal controls aka electronic or procedural controls

A

test systems that include internal monitoring systems and do not require operator calibration or standardization at every use.

25
Q

For certain tests, when are laboratories allowed to reduce the frequency of using external controls?

A

If an instrument is shown to have internal monitoring systems that are reliable

-use of these internal systems are called equivalent QC.

26
Q

Standard

A

a chemical solution of a known concentration that can be used as a reference or calibration substance

standards are aka reference materials

  • more expensive than controls, not usually used on a daily basis
27
Q

What are Standards used for?

A

to calibrate newly purchased instruments and recalibrate instruments after repair, at manufacturer’s recommended intervals, or if a problem is suspected with a test method

28
Q

Calibration

A

refers to the process of checking, standardizing or adjusting a method or instrument so that it yields accurate results.

29
Q

All analytical instruments must be __________ at set intervals, controls must be run regularly to verify calibration, and these actions must be _____________.

A

calibrated, documented

30
Q

Accuracy

A

the closeness of a measured value to the actual, or true value.

31
Q

precision

A

the reproducibility of results or the closeness of obtained values to each other

32
Q

random errors

A

errors for which the source cannot be definitely identified.

  • can occur as a result of temporary variations in voltage, temperature changes, pipetters, dispensers, air bubbles in a reagent line, or differences in technique among workers.
  • can also be caused by interfering substances in patient specimens because of diet, medication, disease or other factors
33
Q

systemic error

A

a variation that can make results consistently higher or lower than the actual value.

-caused by deteriorated, contaminated or out-of-date reagents, mechanical trouble in an instrument, or peculiarity in a worker’s technique.

34
Q

statistics

A

the branch of mathematics that deals wit the collection, classification, analysis, and interpretation of numerical data; a collection of quantitative data

35
Q

population

A

entire group or collection of observations

36
Q

sample

A

in statistics; a subgroup of a population

37
Q

mean

A

the average of a set of values

-divide the sum of values by the number of values

38
Q

standard deviation

A

a measure of the scatter of the sample values around the mean

39
Q

variance

A

the square of the standard deviation; mean square deviation

40
Q

gaussian curve

A

aka normal frequency; or normal distribution curve.

-a graph plotting the distribution of values around the mean

41
Q

shift

A

an abrupt change from the established mean indicated by the occurrence of all control values on one side of the mean

-errors usually caused by reagents and the instrument

42
Q

westgard’s rules

A

these rules list specific limits about how much variation is acceptable in control values before patient test results are rejected

-to use these rules the lab must analyze two different levels of control (normal and abnormal) along with each set of patient samples

43
Q

A patient’s results must be rejected if any of the following is true:

A
  1. both controls are outside the +/- 2s limit
  2. the sane control level is outside the +/- 2s limit in two successive runs
  3. controls in four consecutive runs have values greater than +/- 1s all in the same direction
  4. ten consecutive control values fall on one side of the mean
44
Q

when a lab changes from one method of analysis to another, the _________ of the new method must be ______________ to that of the old one, by calculating the __________________________

A

precision, compared, coefficient of variation

45
Q

Coefficient of variation

A

a calculated value that compares the relative variability between two different sets of values by expressing each standard deviation as a percentage of the mean

Quality Assurance and Laboratory Mathematics (2 decks)

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