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Clinical Chemistry > Quality Control > Flashcards

Quality Control Flashcards

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1
Q

Assessment of control values used to evaluate Quality Assurance

A

Mean
SD

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2
Q

A system in recognizing and MINIMIZING ANALYTICAL ERRORS.

A

Quality Control

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3
Q

This is done EVERYDAY and is FIRST to perform before patients samples are tested, processed and released.

A

Quality Control

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4
Q

Purpose of Quality Control

A

Monitor Analytical Processes (to ensure accuracy and precision)
Detect Analytical Errors
Prevent incorrect reporting of results.

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5
Q

Objectives of Quality Control

Mnemonics:
SM
QR
TE

A

CHECK: Machine-Reagent-Errors

(S)tability of (M)achines
(Q)uality of (R)eagents
(T)echnical (E)rrors

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6
Q

Two (2) known samples in the Laboratory

A

Standard
Control

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7
Q

Two types of ANALYTICAL ERRORS

A

RandoM
SystematiC

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8
Q

It is the most common cause of error in the Laboratory

A

Patient Misidentification

Note: Clerical Error is also HIGHEST source of error in the Laboratory. Patient misidentification is a type of Clerical Error.

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9
Q

Turn around time (TAT) is incorporated in the ________, _________, ________.

A

Pre-analytical Phase
Analytical Phase
Post-analytical Phase

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10
Q

STAT

A

Greek: STATIM “immediately”

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11
Q

Processing of STAT specimens

A

Within 30 to 60 minutes

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12
Q

Random Error and Systematic Error are errors involved in ___________.

A

Analytical Errors

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13
Q

Rando(M) Errors

Error: ________
Cause: _________
Test: _______ *Mnemonics: SPF

A

Error: Indeterminate; Varies sample to sample; By chance; Individual differences
Cause: Imprecision
Test: SD, CV, F-test

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14
Q

Systemati(C) Errors

Error: ________
Cause: _________
Test: _______ *Mnemonics: MAT

A

Error: Determinate, Consistent in one direction; Constant differences
Cause: Inaccuracy:

Test: Mean, T-test

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15
Q

Causes of Random Errors

Mnemonics: I’M POTI DiVo

A

(I)nstrumentation sudden malfunction
(M)islabeling
(P)ipetting Error
(O)perator Error
(T)emperature fluctuation
(Di)rty Optics
(Vo)ltage problem

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16
Q

Causes of Systematic Errors

Mnemonics: DICC (F)rom (W)innie the (P)ooh

A

(D)etorriorating Reagent
(I)mproperly made standard reagent
(C)ontaminated soutions
(C)alibration problems
(From)ailing Instrumentation
(Winne)rong reagent blank
(Po)orly written procedures

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17
Q

Errors caused by handwritten labels, request forms, and results.

A

Clerical Error

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18
Q

Clerical errors are __________, and __________ errors.

A

Pre-analytical and Post-analytical

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19
Q

Variation

A

Errors that occurs in collection, preparation, and measurement of SAMPLES.

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20
Q

Variation are errors in _________, and _________.

A

Analytical and Post-analytical

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21
Q

___________ are specimens analyzed for QC purposes.

A

QC materials

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22
Q

A known analyte solution with ONE sample resembling human sample and MOST SPECIFIC analytical solution.

A

Standard Reagent

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23
Q

Universal Color of Standard

A

Colorless

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24
Q

A known analyte solution with MULTIPLE sample resembling human sample

A

Control Reagent

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25
Q

Universal Color of Controls

A

Yellow - Serum like

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26
Q

Number of Control Solutions:
General Chemistry, _____ levels of control solution
Immunoassays, _____ levels of control solution

A

General Chemistry - Two (2)
Immunoassays - Three (3)

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27
Q

Two Level of control solutions in General Chemistry

A

Normal Control
High Abnormal Control

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28
Q

ROUTINELY USED SOURCE of control solution that is a non-biohazard animal serum

A

Bovine-based Control

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29
Q

A specimen that should never be accepted (both as a control and sample) in the Laboratory

A

Hemolyzed Samples

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30
Q

Control solutions (pooled human sera) are and should be ____________, ___________, ___________.

A

Non-icteric
Non-hemolyzed
Non-infectious

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31
Q

What are the accepted and rejected specimens for control solutions and samples?

A

Accept control if; non-icteric, non-hemolyzed, Non-infectious.
Reject control if; icteric, hemolyzed, infectious

Accept sample if; icteric, non-hemolyzed, lipemic, infectious
Reject sample if; Hemolyzed

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32
Q

A type of QC that provide a DAILY MONITORING of accuracy and precision to detect systematic and random error EVERYDAY.

A

Intralab QC

33
Q

Interlab QC provides a ________ accuracy of the analytical method and involve Proficiency Testing

A

Long Term

34
Q

Method used to validate a particular measurement process. The results are compared with other external laboratories to give an objective indication of test accuracy for LABORATORY ACCREDITATION.

A

Proficiency Testing (Interlab QC)

35
Q

Gold Standard for External Laboratory QC

A

NEQAS/EQAP

36
Q

ISO 15189: 2007

A

Effort by CAP to improve PATIENT CARE through QUALITY LABORATORY PRACTICE

37
Q

Number of samples that are sent yearly recommended by CAP for proficiency testing

A

Before: Annually or periodically (once a year); 12 samples
Current (2019): Bi-annually (twice a year); 6 samples

38
Q

Measures the smallest amount of concentration of the analyte or a.k.a Detection of Limit (doT)

A

Analytical Sensitivity

39
Q

Portion of individuals to detect the PRESENCE/WHO HAVE the disease.

A

Diagnostic Sensitivity

40
Q

Measures the ONLY ONE analyte of interest

A

Analytical Specificity

41
Q

Nearness of the values to the TRUE VALUE

A

Accuracy

42
Q

Nearness of the values to EACH OTHER

A

Precision/Reproducibility

43
Q

Accuracy and precision OVER TIME

A

Reliability

44
Q

Degree which the method can be easily REPEATED/REPLICATED

A

Practicability

45
Q

Portion of the individuals to detect the ABSENCE/WITHOUT the disease

A

Diagnostic Specificity

46
Q

__________ are the expected values that are represented by intervals of acceptable values with
upper and lower limits.

A

Control Limits

47
Q

Highly Sensitive Methods results to __________.
Highly Specific Methods results to ___________.

A
  1. False positive
  2. False negative
48
Q

1SD:__________
2SD:__________
3SD:__________

A

1SD: Gold Standard
2SD: Ideal SD; warning
3SD: Reject; correct

49
Q

Predictive Value Theory (March, 2019)

A

a.k.a Baye’s Theorem
States the relationship between pre-tests and post-tests

50
Q

Tests for Imprecision

A

SD
Precision
F-test

51
Q

Test for Inaccuracy

A

Mean
Accuracy
T-test

52
Q

Most frequently used measure of VARIATION/IMPRECISION

A

SD

53
Q

Acceptable CV

A

CV: 2-4%

54
Q

___________ signifies CONSTANT SYSTEMATIC ERROR.

A

Y-intercept

55
Q

Gussian Curve

A

a.k.a Norma Bell Shaped Curve
65-95-99 rule
Best: Establishing reference values
Mean and SD

56
Q

Cumulative Sum Graph

A

a.k.a CuSum
Detect Change and early systematic (trend) error
Most common method: V-mask

57
Q

Youden Plot

A

a.k.a Twin plot (2 - samples; laboratories)
Best: Interlab QC

58
Q

Shewart Levey Jennings Chart

A

a.k.a Dot Plot
Most commonly used QC chart
Detect trend, shift, outliers and utilizes Westgard rules

59
Q

EWMA

A

a.k.a Exponentially Weighted Moving Average Chart
Average for a specified number of previous results with newer results having more influence (weighted)

60
Q

Number of QC charts for daily monitoring

A

12 charts

61
Q

_____________ is a measure of the organization’s products or services against specific standards for COMPARISON and IMPROVEMENT.

A

Benchmarking (productivity and services)

62
Q

Best Charts.
Internal QC: ___________
External QC: ___________

A

Internal QC: Levey Jennings Chart
External QC: Youden/Twin Plot

63
Q

Warning Rule

A

1 2S

64
Q

Should 1 2S be accepted?

A

Yes. Other rules are rejected.

65
Q

1 3S needs ___________ measure.

A

Corrective. It is Rejected, then it will only be accepted if corrected.

66
Q

The range or difference of +-2SD, that is > than 4SD

A

R 4S

67
Q

__________ provides a culture, infrastructure, methodology and metric toward QUALITY IMPROVEMENT

A

Lean Six Sigma

68
Q

Pioneer in the field of Quality Improvement (Lean Six Sigma)

A

Dr. J. M. Juran

69
Q

Lean Six Sigma is the _______________ that distinguishes an organization.

A

Rate of Improvement

70
Q

Six Sigma reduces _____________.

A

Laboratory Errors

71
Q

Reporting of errors

A

Deficit per million opportunities (DPMO)

72
Q

Lean System reduces _____________.

A

Laboratory waste

73
Q

5S used in Lean System

A

5S:

Sort
Set in order
Shine
Standardize
Sustain

74
Q

PDCA

A

Plan
Do
Check
Act

75
Q

DMAIC

A

Define
Measure
Analyze
Improve
Control

76
Q

Function of DMAIC five phase methodology

A

Ensure sound problem solving
Root cause analysis

77
Q

Most common Lean Six Sigma Team Roles.
Blue: _______
Black: _______
Green: _______

A

Blue: Project Sponsors
Black: Project Leader
Green: Project team member

78
Q

Non-laboratory personnel are responsible for ____% of the error

A

29%

Clinical Chemistry (20 decks)

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