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Liz's Clinical Chemistry Module 1 > Intro to Stats and QC > Flashcards

Intro to Stats and QC Flashcards

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1
Q

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

A

Quality assurance (QA)

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2
Q

Quantitative techniques and procedures which monitor performance parameters

A

Quality control (QC)

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3
Q

List pre-analytical factors

A
  1. Ordering of tests
  2. Patient prep
  3. Patient ID
  4. Specimen collection
  5. Specimen transport to the lab
  6. Specimen handling in transport and in the lab
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4
Q

List analytical factors

A
  1. Use of integral and external quality control programs
  2. Labeling and use of reagents
  3. calibration procedures
  4. maintenance procedures
  5. monitoring of equipment
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5
Q

List post-analytical factors

A
  1. Verification of calculations
  2. Review of results for possible error
  3. Reporting of test results
  4. Interpretation of test results
  5. Competency and adequacy of staff
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6
Q

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

A

Assayed controls

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7
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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8
Q

3 purposes of QC programs

A
  1. Assess accuracy
  2. assess precision
  3. Identify any analytical errors which may be present that may jeopardize patient care
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9
Q

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

A

Accuracy

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10
Q

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

A

Precision

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11
Q

Those errors which occur w/o prediction or regularity; affect SD

A

Random error

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12
Q

Those errors which occur w/in the test system or methodology that occurs regularly; affects accuracy

A

Systematic error

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13
Q

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

A

Proportional systematic error

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14
Q

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

A

Constant systematic error

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15
Q

A sample of known concentration that is used to calibrate or set an instrument’s parameters; has a specific concentration, not a range of concentrations; may be primary or secondary

A

Standard

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16
Q

A sample w/ 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 taht patient values are accurate and precise and may be reported

A

Control

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17
Q

A field of study concerned w/ 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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18
Q

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

A

Descriptive statistics

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19
Q

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

A

Gaussian (Normal) distribution

20
Q

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

A

Mean

21
Q

Most frequently obtained value

A

Mode

22
Q

The value in the middle of the distribution

A

Median

23
Q

The difference b/w the highest and lowest values in a set

A

Range

24
Q

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

A

Variance

25
Q

Describes the spread of data about the mean

A

Standard deviation

26
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 (CV)

27
Q

Limits b/w which a specified proportion of a population is expected to lie

A

Confidence limit (or interval)

28
Q

% w/in +/- 1 SD

A

68.2%

29
Q

% w/in +/- 2 SD

A

95.5%

30
Q

% w/in +/- 3 SD

A

99.7%

31
Q

Causes of constant error

A
  1. Presence of interfering substances in all samples are reagents
  2. Presence of interfering substances in reaction b/w the analyte and the reagent
  3. presence of interfering substances that destroy or inhibit the reagent
32
Q

Causes of proportional error

A
  1. Incorrect assignment of the amount of substance in the calibrator
  2. Occurrence of a side reaction of the analyte
33
Q

Lab confidence limits

A

95% confidence

  • mean +/- 2 SD
  • 1/20 will be out
34
Q

Purposes of internal QC

A

To ensure accuracy and precision of testing methodology

35
Q

CLIA ‘88 requirements

A

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

36
Q

Time frame assessed in internal QC

A

Daily, “real time”

37
Q

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

A

Analytical run

38
Q

Purpose of external QC

A

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

39
Q

External QC time frame assessed

A

2-3 months before results are compiled

40
Q

Process of external QC

A

Pooled samples distributed (CAP); analyzed like patient sample

41
Q

What do you do if QC is out?

A
  1. Check lot #
  2. Rerun the sample bottle of QC
  3. Run another bottle of same level of QC
  4. Run another level of QC
  5. Check Levey-Jennings charts
  6. Run assayed control
  7. Recalibrate or perform maintenance
42
Q

QC #1 ⬆️ but QC #2 is ok, what do you do?

A

Repeat QC #1

43
Q

Repeated QC #1 and still ⬆️, what do you do?

A

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

44
Q

Both QC #1 and #2 are ⬇️, what do you do?

A

Instrument or reagent problems, repeat first

45
Q

QC #1 ⬆️ QC #2 ⬇️, what do you do?

A

Instrument or reagent problem, calibrate, look at Levey-Jennings charts

Liz's Clinical Chemistry Module 1 (5 decks)

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