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Chemistry Module 1 > Intro To Stat Concepts & QC > Flashcards

Intro To Stat Concepts & QC Flashcards

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0
Q

Quantitative techniques & procedures which monitor performance parameters

A

Quality control (QC)

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1
Q

A broad spectrum of plans, policies, & procedures which provide for achievement of quality goals in the lab

A

Quality assurance (QA)

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2
Q

List pre-analytical factors

A

Ordering of tests, patient prep, patient ID, specimen collection, specimen transport to the lab, specimen handling in transport and in the lab

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3
Q

List analytical factors

A

Use of integral and external quality control programs, labeling and use of reagents, calibration procedures, maintenance procedures, monitoring of equipment

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4
Q

List post-analytical factors

A

Verification of calcs, review of results for possible error, reporting of test results, interpretation of test results, competency and adequacy of staff

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5
Q

Defined ranges determined by the manufacturer; used for periodic accuracy checks

A

Assayed controls

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6
Q

Each laboratory determines it’s own particular range; used to check accuracy and precision of daily patient results

A

Unassayed controls

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7
Q

3 purposes of QC programs

A

1 assess accuracy
2 access precision
3 identify any analytical errors which may be present that may jeopardize patient care

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8
Q

The measure of the correctness of a result; how close the result comes to a true value

A

Accuracy

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9
Q

A measure of reproducibility; the measure of the variability present in an analytical process

A

Precision

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10
Q

Those errors which occur without prediction or regularity ; affect SD

A

Random error

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11
Q

Those error which occur within the test system or methodology that occur regularly; affects accuracy

A

Systematic error

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12
Q

Those errors that are proportional to analyte conc; error increases in magnitude as conc increases

A

Proportional systematic error

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13
Q

Those errors which are constant or in the same amount over the entire range of analyte conc

A

Constant systematic error

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14
Q

A sample of known conc that is used to calibrate or set an instruments parameters; has a specific conc, not a range if concentrations; may be primary or secondary

A

Standard

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15
Q

A sample with a range of concentrations either determined by the manufacturer (assayed) or determined by the particular lab (Unassayed); used to determine if we may be reasonably assured that patient values are accurate and precise and may be reported

A

Control

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16
Q

A field of study concerned with the organization and summarization of data and drawing of inferences about a body of data when only part of the data is observed

A

Statistics

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17
Q

Used to summarize the important features of a group of data; concerned with the mean, range, variability, and distribution of a data set

A

Descriptive statistics

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18
Q

With enough data points, the plot will be a predictable, bell shaped curve

A

Gaussian (Normal) distribution

19
Q

Center of distribution determined from the sum of the values divided by the number of values. Average, expressed as x, reported in same units as test. Representative of the central tendency of population only if histogram is symmetric about the mean.

A

Mean

20
Q

Most frequently obtained value

A

Mode

21
Q

The value in the middle of the distribution

A

Median

22
Q

The difference between the highest and lowest values in a set

A

Range

23
Q

A measure of the average squared distance of data points from the mean

A

Variance

24
Q

Describes the spread of data about the mean.

A

Standard deviation

25
Q

The size of the standard deviation in relationship to the mean; expressed as percent; useful to compare deviations of different pools and different data

A

Coefficient of variation

26
Q

Limits between which a specified proportion of a population is expected to lie

A

Confidence limit (or interval)

27
Q

% within +- 1 SD

A

68.2%

28
Q

% within +- 2 SD

A

95.5%

29
Q

% within +- 3 SD

A

99.7%

30
Q

Causes of constant error

A

Presence of interfering substances in all samples or reagents; presence of interfering substances in reaction between the analyte and reagent; presence of interfering substances that destroy or inhibit the reagent

31
Q

Causes of proportional error

A

Incorrect assignment of the amt of substance in the calibrator; occurrence of a side reaction of the analyte

32
Q

Lab confidence limits

A

95% confidence or a mean of +- 2 SD, 1 out of 20 will be out

33
Q

Purpose of internal QC

A

To ensure accuracy and precision of testing methodology

34
Q

CLIA ‘88 requirements

A

Two levels of QC must be analyzed every 24 hours for each test performed that day

35
Q

Time frame assessed in internal QC

A

Daily, “real time”

36
Q

The period of time between which the instrument or procedure is expected to be stable or period of time between QC analyses; run 2 levels at least every 24 hours for daily tests

A

Analytical run

37
Q

Purpose of external QC

A

To compare quality of our lab to those in other parts of the state/country

38
Q

External QC time frame assessed

A

2-3 months before results are compiled

39
Q

Process of external QC

A

Pooled samples distributed (CAP); analyzed like any patient sample

40
Q

What do you do if QC is out?

A 
1 check lot #
2 rerun same bottle of QC
3 run another bottle of same level QC
4 run another level of QC
5 check levey-Jennings charts
6 run assayed control 
7 recalibrate or perform maintenance
41
Q

QC #1 ⬆️ QC #2 ok

A

Repeat QC #1

42
Q

Repeated QC #1 and still ⬆️

A

See if bottle expired, new bottle, can rule out reagent or instrument

43
Q

Both QC #1 & 2 are ⬇️

A

Instrument or reagent problems, repeat first

44
Q

QC #1 ⬆️ QC #2 ⬇️

A

Instrument or reagent problem, calibrate, look at levey-Jennings

Chemistry Module 1 (18 decks)

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