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CLINICAL CHEMISTRY > Quality Assessment > Flashcards

Quality Assessment Flashcards

(103 cards)

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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
Bovine Control Materials is used preferred control but cannot be used to (3)
Immunochemistry Dye-binding Bilirubin assays
26
Reconstitution is required to avoid incorrect control values
Lyophilized Control Materials
27
Do not require reconstitution but may have different characterization compared to actual patient specimens
Stabilized Frozen Controls
28
Characteristics of a Ideal Control Materials
- Resembles Human sample - Inexpensive and Stable - No matrix effects - No communicable disease - With known analyte concentration - Convenient packaging (Storage and dispensing)
29
Process of testing and adjusting analyzer's readout to establish correlation between MEASURED and ACTUAL CONCENTRATION
Calibration
30
Reference material WITH KNOWN CONCENTRATION of analyte
Calibrator
31
Previosly known as STANDARD
Calibrator
32
It is a substance programmed in the computer's analyzer for calculating concentration of UNKNOWNS
Calibrator/Standard
33
Testing of Materials of Known Concentration - Calibrators - Control - Proficiency testing samples - Patient with known values TO ENSURE ACCURACY OF RESULT
Calibration Verification
34
Calibration Verification test how many levels?
3 High Midpoint Low
35
Calibration Verification is required to have every
- every 6 months - change in # of reagent slot - preventing preventive maintenance/repair - controls are out of range
36
Statistical parameters describing spread of data
Measure of dispersion
37
Measure of Dispersion includes (4)
Mean Range Standard Deviation Coefficient of Variance
38
Difference Between highest and Lowest in data set
Range
39
Sum of all observations divided by number of observations. AVERAGE of all observations
Mean
40
Statistical expression of dispersion of values around the mean.
Standard Deviations
41
Standard deviation minimum requirement of values
20
42
Standard deviation as percentage
Coefficient of Variation
43
The higher the CV; the ____ the precision
Lower
44
Population Probability Distribution that is SYMMETRIC about the Mean
Gaussian Curve (Bell-shaped curve)
45
Gaussian Curve (Bell-shaped curve) - Values fall within + 1SD
68%
46
Gaussian Curve (Bell-shaped curve) - Values fall within + 2SD
95.5%
47
Gaussian Curve (Bell-shaped curve) - Values fall within + 3SD
99.7%
48
GUASSIAN Bell-shaped curved: HAXI
Horizontal Abscissa X-Axis Independent Values
49
GUASSIAN Bell-shaped curved: VOYD
Vertical Ordinate Y-axis Dependent Values
50
Calculates differences between WC result and Targeted mean.
CUSUM (Cumulative Sum Graph)
51
Earliest detection of Systematic Error (Shift)
CUSUM
52
Compare results on high and Low control serum from different lab
Youden/Twin plot
53
Most widely used; graphic representatio of acceptable limits of variation in the results of analytical method Easily identifies random and systematic errors
Shewhart-Levey Jenning Chart
54
Range within which control values must fall for assay to be CONSIDERED VALID
control limits
55
Control result outside established limits
Outliers
56
6 consecutive control values on the Same side of Mean
Shift
57
Sudden/Abrupt change causes
Shift
58
Shift is due to
Improper Calibration
59
6 consecutive control values in decreasing or Increasing side of mean
Trend
60
Gradual loss of reliability
Trend
61
Main cause of Trend
Reagent Deterioriation
62
Unpredictable, Indeterminate, IMPRESICION
Random Error
63
Error that doesn't occur on regular pattern due to ENVIRONMENT and Operator
Random Error
64
Control values that exceeds in Random Error
R4s, 13s
65
Determinate, Predictable, INACCURACY
Systematic error
66
Recurring error inherent in test procedure, CONSISTENTLY in one direction
Systematic Error
67
Indicated by TREND or SHIFT ON Levey-Jennings
Systematic Error
68
Rejection of Run because QC results indicate problem when none is present
False Rejection
69
If a violation of a westgard rule occurs, actions to take are:
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
How close measurement is to true value
Accuracy
71
Reproducibility. How close results are when same sample is tested multiple times
Precision
72
Range of values over which lab can verify accuracy of test system; Also known as LINEARITY
Reportable Range
73
Formerly called as NORMAL VALUES. Can very for different patient population (age, gender, race)
Reference Interval
74
Number of healthy individuals needed to established Reference interval
120 healthy individuals
75
- Detection Limit - Lowest Concentration of substance is detected - Screening Test - Decreased False negative
Analytical Sensitivity
76
- Ability of Method to detect only the desire substance/analyte - Increased specificity; Decreased False Positive ; Decreased cross-reactivity
Analytical Specificity
77
Pos result in patient who has disease
True Positive
78
Neg result who does not have disease
True Negative
79
Positive result who does not have disease
False Positive
80
Negative Result who does have the disease
False Negative
81
% population with the disease with (+) result
Diagnostic Sensitivity
82
% population without the disease with (-) result
Diagnostic Specificity
83
% of time that the (+) result is correct
Positive Predictive Value
84
% of time that the (-) result is correct
Negative Predictive Value
85
proportion of cases with a SPECIFIC DISEASE that give a POSITIVE result
Sensitivity
86
proportion of cases WITHOUT SPECIFIC DISEASE that give a NEGATIVE result
Specificity
87
test indicates the number of patients with an abnormal Test result who do have the disease; compared with all patients with an abnormal result
Positive Predictive Value
88
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
Negative Predictive Value
89
Monitoring and Diagnosing of Disease (4)
1. Diagnostic Sensitivity 2. Diagnostic Specificity 3. PPV 4. NPV
90
Study to verify accuracy of new methods
Correlation study
91
Individuals needed for Correlation Study
40 patients samples
92
Perfect correlation is straight line passing through 0 at ___ angle
45 deg angle
93
Correlation Study Result: 0 = +1 = >0.95 =
0 = No correlation +1 = Perfect correlation >0.95 = Excellent correlation
94
Schedule of maintenance to keep equipment in peak operating condition.
Preventive maintenance
95
Procedures specified by manufacturer to evaluate critical operating characteristics of test.
Functional check
96
testing only those who are at high risk for exposure and for those who have symptoms
Targeted testing
97
Comparison of patient with previous results.
Delta check
98
Test results that indicates POTENTIALLY LIFE-THREATENING SITUATION
Critical Values
99
Critical Values includes
Glucose Na K Total CO2 Calcium Magnesium Phosphorus Total Bilirubin (neonates) Blood gases
100
In cases of Critical values, patient care personnel must be NOTIFIED _____
IMMEDIATELY
101
The joint commission requires _____ policy incases of Critical values.
Read-back policy - person receiving critical values must record and read back patient's name and critical values.
102
CLIA requires documentation of competency assessment on HIRE AT 6 MONTHS AND THEN ANNUALLY
Personnel competency Assessment
103
Testing of unknowns submitted by OUTSIDE AGENCY e.g CAP
Proficiency Testing

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