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CLINICAL CHEMISTRY > Quality Assessment > Flashcards

Quality Assessment Flashcards

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1
Q

Ensures quality results by closely monitoring PRE-ANALYTICAL, ANALYTICAL, POST-ANALYTICAL

A

Quality assessment/ Quality Assurance

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2
Q

Primary Goal of Quality Assurance/Quality Assessment

A

Ensure quality service and products to customers

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3
Q

Everything precedes test performance:

  • Test Ordering
  • Specimen Collection
  • Patient Preparation
  • Patient Identification
  • Specimen Transport
  • Specimen Processing
A

Pre-analytical

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4
Q

Everything related to assay
- Test analysis
- QC
- Calibration
- Preventive Maintenance

A

Analytical

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5
Q

Everything that comes after the test analysis
- verification of calculation & reference ranges
- review of results
- notification of critical values
- result reporting
- test interpretation by physician
- follow-up patient care

A

Post-Analytical phase

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6
Q

World largest developer and publisher of International standards

A

International Organization for Standardization (ISO)

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7
Q

Use by Medical Laboratories in developing their quality management systems and assessing their own competence, use by ACCREDITATION BODIES in confirming or recognizing the competence of medical laboratories

A

ISO 15189: 2007

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8
Q

The Joint Commission previously known as

A

JCA-HO
Joint Commission on Accreditation of Healthcare Organization

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9
Q

Aside from TJC itself, laboratory are mandated to be accredited with (2)

A

COLA
Commission on Office Laboratory Accreditation

CAP
College of American Pathologist

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10
Q

TJC announced PPR which is required for laboratory accreditation program; PPR is also known as

A

Periodic Performance Review

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11
Q

Part of Analytical Phase of quality assurance

system ENSURING DAILY ACCURACY AND PRECISION IN LABORATORY

A

Quality Control
Intralab/Internal QC

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12
Q

Sample that is chemically and physically similar to UKNOWN specimen; Tested in same exact manner

A

Control

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13
Q

Monitors precision of test system

A

Control

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14
Q

For non-waived quantitative test, CLIA requires at least ___ levels id controls each day

A

2

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15
Q

For qualitative test, _____ and ____ must be included in the run

A

Positive and Negative control

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16
Q

Testing control not built into the system

A

External EC/Interlab QC

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17
Q

Term is also used for QC extends beyond Lab; Proficiency Testing Program

A

External QC/Interlab

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18
Q

Long term accuracy of analytical Method

A

External QC/ Interlab QC

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19
Q

Gold Standard of External QC/Interlab QC

A

College of American Pathologists Proficiency Program (CAP)

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20
Q

Electronic, Internal, procedural controls that are built into test systems

A

Internal Monitoring System

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21
Q

Labs may reduced frequency of testing External QC for certain test system if they can demonstrate a CMS-approved QC evaluation that test is STABLE

A

Equivalent QC

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22
Q

CMS stands for

A

Center for Medicare and Medicaid Services

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23
Q

These are the preferred type of control but is prone to biohazard cautions

A

Human control materials

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24
Q

Instead of Human Control Materials, it is use since it is free from biohazard cautions

A

Bovine Control Material

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25
Q

Bovine Control Materials is used preferred control but cannot be used to (3)

A

Immunochemistry
Dye-binding
Bilirubin assays

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26
Q

Reconstitution is required to avoid incorrect control values

A

Lyophilized Control Materials

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27
Q

Do not require reconstitution but may have different characterization compared to actual patient specimens

A

Stabilized Frozen Controls

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28
Q

Characteristics of a Ideal Control Materials

A
  • Resembles Human sample
  • Inexpensive and Stable
  • No matrix effects
  • No communicable disease
  • With known analyte concentration
  • Convenient packaging (Storage and dispensing)
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29
Q

Process of testing and adjusting analyzer’s readout to establish correlation between MEASURED and ACTUAL CONCENTRATION

A

Calibration

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30
Q

Reference material WITH KNOWN CONCENTRATION of analyte

A

Calibrator

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31
Q

Previosly known as STANDARD

A

Calibrator

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32
Q

It is a substance programmed in the computer’s analyzer for calculating concentration of UNKNOWNS

A

Calibrator/Standard

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33
Q

Testing of Materials of Known Concentration
- Calibrators
- Control
- Proficiency testing samples
- Patient with known values

TO ENSURE ACCURACY OF RESULT

A

Calibration Verification

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34
Q

Calibration Verification test how many levels?

A

3

High
Midpoint
Low

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35
Q

Calibration Verification is required to have every

A
  • every 6 months
  • change in # of reagent slot
  • preventing preventive maintenance/repair
  • controls are out of range
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36
Q

Statistical parameters describing spread of data

A

Measure of dispersion

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37
Q

Measure of Dispersion includes (4)

A

Mean
Range
Standard Deviation
Coefficient of Variance

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38
Q

Difference Between highest and Lowest in data set

A

Range

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39
Q

Sum of all observations divided by number of observations. AVERAGE of all observations

A

Mean

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40
Q

Statistical expression of dispersion of values around the mean.

A

Standard Deviations

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41
Q

Standard deviation minimum requirement of values

A

20

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42
Q

Standard deviation as percentage

A

Coefficient of Variation

43
Q

The higher the CV; the ____ the precision

A

Lower

44
Q

Population Probability Distribution that is SYMMETRIC about the Mean

A

Gaussian Curve (Bell-shaped curve)

45
Q

Gaussian Curve (Bell-shaped curve)
- Values fall within + 1SD

A

68%

46
Q

Gaussian Curve (Bell-shaped curve)
- Values fall within + 2SD

A

95.5%

47
Q

Gaussian Curve (Bell-shaped curve)
- Values fall within + 3SD

A

99.7%

48
Q

GUASSIAN Bell-shaped curved:

HAXI

A

Horizontal
Abscissa
X-Axis
Independent Values

49
Q

GUASSIAN Bell-shaped curved:

VOYD

A

Vertical
Ordinate
Y-axis
Dependent Values

50
Q

Calculates differences between WC result and Targeted mean.

A

CUSUM (Cumulative Sum Graph)

51
Q

Earliest detection of Systematic Error (Shift)

A

CUSUM

52
Q

Compare results on high and Low control serum from different lab

A

Youden/Twin plot

53
Q

Most widely used; graphic representatio of acceptable limits of variation in the results of analytical method

Easily identifies random and systematic errors

A

Shewhart-Levey Jenning Chart

54
Q

Range within which control values must fall for assay to be CONSIDERED VALID

A

control limits

55
Q

Control result outside established limits

A

Outliers

56
Q

6 consecutive control values on the Same side of Mean

A

Shift

57
Q

Sudden/Abrupt change causes

A

Shift

58
Q

Shift is due to

A

Improper Calibration

59
Q

6 consecutive control values in decreasing or Increasing side of mean

A

Trend

60
Q

Gradual loss of reliability

A

Trend

61
Q

Main cause of Trend

A

Reagent Deterioriation

62
Q

Unpredictable, Indeterminate, IMPRESICION

A

Random Error

63
Q

Error that doesn’t occur on regular pattern due to ENVIRONMENT and Operator

A

Random Error

64
Q

Control values that exceeds in Random Error

A

R4s, 13s

65
Q

Determinate, Predictable, INACCURACY

A

Systematic error

66
Q

Recurring error inherent in test procedure, CONSISTENTLY in one direction

A

Systematic Error

67
Q

Indicated by TREND or SHIFT ON Levey-Jennings

A

Systematic Error

68
Q

Rejection of Run because QC results indicate problem when none is present

A

False Rejection

69
Q

If a violation of a westgard rule occurs, actions to take are:

A
  1. accept result when 12s = warning
  2. Reject result if westgard rule is violated
  3. Increase retesting range if either a warning or mandatory rules are violated
70
Q

How close measurement is to true value

A

Accuracy

71
Q

Reproducibility. How close results are when same sample is tested multiple times

A

Precision

72
Q

Range of values over which lab can verify accuracy of test system; Also known as LINEARITY

A

Reportable Range

73
Q

Formerly called as NORMAL VALUES. Can very for different patient population (age, gender, race)

A

Reference Interval

74
Q

Number of healthy individuals needed to established Reference interval

A

120 healthy individuals

75
Q
  • Detection Limit
  • Lowest Concentration of substance is detected
  • Screening Test
  • Decreased False negative
A

Analytical Sensitivity

76
Q
  • Ability of Method to detect only the desire substance/analyte
  • Increased specificity; Decreased False Positive ; Decreased cross-reactivity
A

Analytical Specificity

77
Q

Pos result in patient who has disease

A

True Positive

78
Q

Neg result who does not have disease

A

True Negative

79
Q

Positive result who does not have disease

A

False Positive

80
Q

Negative Result who does have the disease

A

False Negative

81
Q

% population with the disease with (+) result

A

Diagnostic Sensitivity

82
Q

% population without the disease with (-) result

A

Diagnostic Specificity

83
Q

% of time that the (+) result is correct

A

Positive Predictive Value

84
Q

% of time that the (-) result is correct

A

Negative Predictive Value

85
Q

proportion of cases with a SPECIFIC DISEASE that give a POSITIVE result

A

Sensitivity

86
Q

proportion of cases WITHOUT SPECIFIC DISEASE that give a NEGATIVE result

A

Specificity

87
Q

test indicates the number of patients with an abnormal Test result who do have the disease; compared with all patients with an abnormal result

A

Positive Predictive Value

88
Q

test indicates the number of patients with an Normal result (negative) who do not have the disease; compared with all patients with a normal test (negative) result

A

Negative Predictive Value

89
Q

Monitoring and Diagnosing of Disease (4)

A
  1. Diagnostic Sensitivity
  2. Diagnostic Specificity
  3. PPV
  4. NPV
90
Q

Study to verify accuracy of new methods

A

Correlation study

91
Q

Individuals needed for Correlation Study

A

40 patients samples

92
Q

Perfect correlation is straight line passing through 0 at ___ angle

A

45 deg angle

93
Q

Correlation Study Result:

0 =
+1 =
>0.95 =

A

0 = No correlation
+1 = Perfect correlation
>0.95 = Excellent correlation

94
Q

Schedule of maintenance to keep equipment in peak operating condition.

A

Preventive maintenance

95
Q

Procedures specified by manufacturer to evaluate critical operating characteristics of test.

A

Functional check

96
Q

testing only those who are at high risk for exposure and for those who have symptoms

A

Targeted testing

97
Q

Comparison of patient with previous results.

A

Delta check

98
Q

Test results that indicates POTENTIALLY LIFE-THREATENING SITUATION

A

Critical Values

99
Q

Critical Values includes

A

Glucose
Na
K
Total CO2
Calcium
Magnesium
Phosphorus
Total Bilirubin (neonates)
Blood gases

100
Q

In cases of Critical values, patient care personnel must be NOTIFIED _____

A

IMMEDIATELY

101
Q

The joint commission requires _____ policy incases of Critical values.

A

Read-back policy
- person receiving critical values must record and read back patient’s name and critical values.

102
Q

CLIA requires documentation of competency assessment on HIRE AT 6 MONTHS AND THEN ANNUALLY

A

Personnel competency Assessment

103
Q

Testing of unknowns submitted by OUTSIDE AGENCY e.g CAP

A

Proficiency Testing

CLINICAL CHEMISTRY (29 decks)

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