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Quality Control Flashcards

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
Universal Color of Controls
Yellow - Serum like
26
Number of Control Solutions: General Chemistry, _____ levels of control solution Immunoassays, _____ levels of control solution
General Chemistry - Two (2) Immunoassays - Three (3)
27
Two Level of control solutions in General Chemistry
Normal Control High Abnormal Control
28
ROUTINELY USED SOURCE of control solution that is a non-biohazard animal serum
Bovine-based Control
29
A specimen that should never be accepted (both as a control and sample) in the Laboratory
Hemolyzed Samples
30
Control solutions (pooled human sera) are and should be ____________, ___________, ___________.
Non-icteric Non-hemolyzed Non-infectious
31
What are the accepted and rejected specimens for control solutions and samples?
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
32
A type of QC that provide a DAILY MONITORING of accuracy and precision to detect systematic and random error EVERYDAY.
Intralab QC
33
Interlab QC provides a ________ accuracy of the analytical method and involve Proficiency Testing
Long Term
34
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.
Proficiency Testing (Interlab QC)
35
Gold Standard for External Laboratory QC
NEQAS/EQAP
36
ISO 15189: 2007
Effort by CAP to improve PATIENT CARE through QUALITY LABORATORY PRACTICE
37
Number of samples that are sent yearly recommended by CAP for proficiency testing
Before: Annually or periodically (once a year); 12 samples Current (2019): Bi-annually (twice a year); 6 samples
38
Measures the smallest amount of concentration of the analyte or a.k.a Detection of Limit (doT)
Analytical Sensitivity
39
Portion of individuals to detect the PRESENCE/WHO HAVE the disease.
Diagnostic Sensitivity
40
Measures the ONLY ONE analyte of interest
Analytical Specificity
41
Nearness of the values to the TRUE VALUE
Accuracy
42
Nearness of the values to EACH OTHER
Precision/Reproducibility
43
Accuracy and precision OVER TIME
Reliability
44
Degree which the method can be easily REPEATED/REPLICATED
Practicability
45
Portion of the individuals to detect the ABSENCE/WITHOUT the disease
Diagnostic Specificity
46
__________ are the expected values that are represented by intervals of acceptable values with upper and lower limits.
Control Limits
47
Highly Sensitive Methods results to __________. Highly Specific Methods results to ___________.
1. False positive 2. False negative
48
1SD:__________ 2SD:__________ 3SD:__________
1SD: Gold Standard 2SD: Ideal SD; warning 3SD: Reject; correct
49
Predictive Value Theory (March, 2019)
a.k.a Baye's Theorem States the relationship between pre-tests and post-tests
50
Tests for Imprecision
SD Precision F-test
51
Test for Inaccuracy
Mean Accuracy T-test
52
Most frequently used measure of VARIATION/IMPRECISION
SD
53
Acceptable CV
CV: 2-4%
54
___________ signifies CONSTANT SYSTEMATIC ERROR.
Y-intercept
55
Gussian Curve
a.k.a Norma Bell Shaped Curve 65-95-99 rule Best: Establishing reference values Mean and SD
56
Cumulative Sum Graph
a.k.a CuSum Detect Change and early systematic (trend) error Most common method: V-mask
57
Youden Plot
a.k.a Twin plot (2 - samples; laboratories) Best: Interlab QC
58
Shewart Levey Jennings Chart
a.k.a Dot Plot Most commonly used QC chart Detect trend, shift, outliers and utilizes Westgard rules
59
EWMA
a.k.a Exponentially Weighted Moving Average Chart Average for a specified number of previous results with newer results having more influence (weighted)
60
Number of QC charts for daily monitoring
12 charts
61
_____________ is a measure of the organization's products or services against specific standards for COMPARISON and IMPROVEMENT.
Benchmarking (productivity and services)
62
Best Charts. Internal QC: ___________ External QC: ___________
Internal QC: Levey Jennings Chart External QC: Youden/Twin Plot
63
Warning Rule
1 2S
64
Should 1 2S be accepted?
Yes. Other rules are rejected.
65
1 3S needs ___________ measure.
Corrective. It is Rejected, then it will only be accepted if corrected.
66
The range or difference of +-2SD, that is > than 4SD
R 4S
67
__________ provides a culture, infrastructure, methodology and metric toward QUALITY IMPROVEMENT
Lean Six Sigma
68
Pioneer in the field of Quality Improvement (Lean Six Sigma)
Dr. J. M. Juran
69
Lean Six Sigma is the _______________ that distinguishes an organization.
Rate of Improvement
70
Six Sigma reduces _____________.
Laboratory Errors
71
Reporting of errors
Deficit per million opportunities (DPMO)
72
Lean System reduces _____________.
Laboratory waste
73
5S used in Lean System
5S: Sort Set in order Shine Standardize Sustain
74
PDCA
Plan Do Check Act
75
DMAIC
Define Measure Analyze Improve Control
76
Function of DMAIC five phase methodology
Ensure sound problem solving Root cause analysis
77
Most common Lean Six Sigma Team Roles. Blue: _______ Black: _______ Green: _______
Blue: Project Sponsors Black: Project Leader Green: Project team member
78
Non-laboratory personnel are responsible for ____% of the error
29%

Clinical Chemistry (20 decks)

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