QUALITY MANAGEMENT Flashcards
(53 cards)
1
Q
refers to the overall process used to ensure that laboratory results meet the requirements for health care services to patients.
A
QUALITY MANAGEMENT
2
Q
INTERNATIONAL STANDARDS
- International standard for clinical laboratory
- obtaining process of machines
A
- ISO 15189
- ISO 17025
3
Q
Cycle of Six Sigma Design
A
- Planning (Basis: Int’l Guidelines; CLSI, ISO)
- Laboratory Processes (Inspection , Accreditation)
- Control
- Assessment (SIX SIGMA)
- Risk Management
Redesigning of Six Sigma Design
Balik umpisa
4
Q
- Refers to procedures for monitoring work processes, detecting problems and making corrections prior to the delivery of products and services
- Statistical QC is a major procedure for monitoring the analytical performance of laboratory testing processes
- Focuses on the examination phase
A
QUALITY CONTROL
5
Q
- Refers to the broader monitoring of other dimensions or other characteristics of quality such as turn around time, patient preparation, specimen acquisition and result reporting that are monitored through broad QA (Quality Assurance) activities
- Part of the pre-examination and post-examination
A
QUALITY ASSESSMENT
6
Q
- Aimed at determining the root causes or sources of the problems being identified by QC and QA
- LEAN SIX SIGMA
A
QUALITY IMPROVEMENT
7
Q
Represent the objectives or requirements that must be achieved to satisfy the customers
A
QUALITY GOAL
8
Q
Concerned with establishing and validating processes that meet customer needs.
A
QUALITY PLANNING
9
Q
Basic Concepts in Technical Evaluation and Validation of Equipment
- A confirmation that the requirements for specifically intended use or specific applications were met through OBJECTIVE EVIDENCE (see forms like rubrics for scoring).
- It confirms that the level of measurement is sufficient, the measurement procedures are correct and the calibration was done properly.
- ALL must be done
A
Validation
10
Q
- A confirmation that the analytical characteristics data provided by the manufacturer, a laboratory or reference institution were achieved through OBJECTIVE EVIDENCE in the given laboratory with the use of a specific measuring system.
- It confirms that the measurement method/ measuring system is fully functional in a specific
- Laboratory.
- The manufacturer provides the parameters and it is your task to double-check.
- you can CHOOSE ONE criteria to perform but it must be within precise range.
A
Verification
11
Q
ALL CC Analyzers should:
A
PASSLR
Precision
Accuracy
Specificity
Sensitivity
Linearity
Reference range
12
Q
Types of Validation
- Ability to accurately and reliably measure the analyte of interest in the clinical laboratory and in specimens representative of the population of interest.
- Performance indicators: Specificity, Sensitivity, Linearity
A
Analytical validation
13
Q
- Ability to diagnose or predict risk for a particular health condition, measured by clinical/ diagnostic sensitivity and clinical/diagnostic specificity and predictive values
- Positive predictive value (PPV), and
- Negative predictive value (NPV)
A
Clinical
Validation
14
Q
In the lab, we classify the test as to whether it is waive or non-waive
1. QC and validation or proficiency testing are NOT required
- Simple; Most likely accurate
- With negligible risk of harm if not performed correctly
- CLIA recommendation: follow the manufacturer’s instructions for use
- Eg. rapid test kits (positive or negative)
2. Required QC and validation/proficiency testing
- Moderate complexity (Automated methods
All machines has moderate complexity)
- High complexity (Manual method and methods requiring more interpretation; High patient impact, More technical, Eg. RT-PCR, ELISA, Crossmatching, etc)
A
- Waived
- Nonwaived
15
Q
Reasons for Validation:
- TOF. Results of analytical measurement will DEFINITELY influence health, quality of life and even the patient’s life (for patient safety).
- TOF. It is our NOT OUR professional duty to carry out measurement of sufficient QUALITY (comply with accrediting bodies).
- TOF. Accreditation (official confirmation of laboratory’s competence) requires the use of properly validated and verified measurements.
- TOF. In the lab, we don’t need to classify the test as to whether it is waive or non-waive.
A
- T
- F
- T
- F
16
Q
the amount of error that can be tolerated without invalidating the medical usefulness of the result.
A
Allowable error
17
Q
A method performed to determine is able to accurately measure an analyte.
A
Performance Standard
18
Q
TOTAL ANALYTICAL ERROR
- Described as error that can either positive or negative
- Results from variation of technique
- The one making the mistake is the MedTech
- Maximum size of random error is commonly expressed as 2SD or 3SD estimate
- WG rules (violated): 1:2S, 1:3S, R:4S, (2 levels of control)
- Based on Statistical tests: CV and standard deviation
- High CV = presence of this error
A
Random Error / Imprecision / Random variation
19
Q
TOTAL ANALYTICAL ERROR
- Error that is always at one direction and cause all the TST to be low or high
- Influences observations consistently in one direction (higher or lower)
- error can be estimated by: recovery, interference, and COM (Comparison of Methods)
- Represented by changes in the slope and y-intercept
- WG Rules: 2:2S, 4:1S, 10:X (2 Levels of Controls)
- Deterioration of the reagents (Note for recall)
A
Systematic Error / Bias / Inaccuracy
20
Q
TOTAL ANALYTICAL ERROR
- Refers to the difference between target value and assay value
- Independent of sample concentration
- Test used for determination: interference experiment
A
Constant error
21
Q
TOTAL ANALYTICAL ERROR
- Results in greater deviation from the target value due to higher sample concentration
- Magnitude of error increase with increased sample concentration
- Test used: recovery experiment
A
Proportional error / Slope / Percent error
22
Q
TOTAL ANALYTICAL ERROR
- Net or combined effect of random and systematic error
- Test used: replication and comparison
A
Total analytical error (TAE)
23
Q
TOTAL ANALYTICAL ERROR
Remedy
- stepwise evaluation of the procedure needs to be carried out to determine where the problem lies
- sample is re-assayed using the same reagents
A
- Systematic
- Random
24
Q
2 Types of Ssytematic Bias/Inaccuracy
A
- Proportional Systematic Error
- Constant Systematic Error
25
# Random Error / Imprecision / Random variation
WG rules (violated):
1:2S, 1:3S, R:4S, (2 levels of control)
26
# Systematic Error / Bias / Inaccuracy
WG Rules violated
2:2S, 4:1S, 10:X (2 Levels of Controls)
27
Error is due to
1. Reagent dispensing
1. Sample evaporation
1. Temperature analyzer
1. Fluctuations in line voltage
1. Wear and tear of instrument
Random
Random
Random
Systematic
Systematic
28
Error is due
1. Aging reagents
1. Aging calibrators
1. Electro-optical mechanism
1. Instrument components
1. Optical changes
Systematic
Systematic
Random
Systematic
Systematic
29
Error is due to
1. Calibration reconstitution
1. Wear and tear of instrument
1. Reagent lot variability
1. Environmental conditions
1. Calibration Differences
1. Technologist Interactions
Random
Systematic
Systematic
Random
Systematic
Systematic
30
Error is due to
1. Instability of instrument
2. Technologist Interactions
1. Variation in handling techniques: pipetting, mixing, timing
1. Variation in operators
Random Error
Systematic Error
Random Error
Random Error
31
* Competitive reaction: fluorophores labeled thyroxine competes with patient thyroxine for antibody in (FPIA) homogeneous system. Antibodybound labeled thyroxine rotates slowly, emitting lower energy polarized light. Highest polarized light emitted by sample or standard with no thyroxine.
* Good sensitivity and specificity; moderate complexity; fewer safety regulations to follow compared with radioimmunoassay (RIA).
Fluorescent Polarization Immunoassay (FPIA)
32
# Immunoassay Methods for Tyroxine Testing
* Competitive reaction: fluorogenic substrate-labeled thyroxine competing with patient T4 for antibody in a homogeneous assay. Only unbound, leftover labeled T4 reacts with enzyme to form fluorescent product. Highest fluorescence emitted by sample or standard with highest levels of T4
* Good sensitivity and specificity and no nuclear safety regulations required
Fluorescent Substrate- Labeled Inhibition Immunoassay
33
# Immunoassay Methods for Tyroxine Testing
* Peroxidase-labeled antibody binds with patient hormone (antigen) to form complex (similar to ELISA). Addition of luminol or acidic esters substrate forms an oxidized product that emits light for short time measured by a luminometer.
* Substrate reacts with enzyme label to form fluorescent product.
Chemiluminescence
34
# Immunoassay Methods for Tyroxine Testing
* Similar to enzyme-linked immunosorbent assay (ELISA) in that there is a double-antibody system that forms a “sandwich” with the hormone.
* Sensitivity may be better than other immunoassay methods; highly automated; quick turn-around time and no nuclear safety regulations are required.
Microparticle Enzyme Immunoassay (MEIA)
35
# TYPES OF ANALYTICAL ERROR
Mislabeling a sample/specimen, Pipetting errors, Improper mixing of sample and reagent , Voltage Fluctuations not compensated by for by instrument circuitry, Temperature Fluctuations , operator and environmental conditions
1. Remedy for
2. Test used for determination
RANDOM ERROR
Remedy: Re-assay the sample using the same reagents
Test used for determination: CV and standard deviation
36
# TYPES OF ANALYTICAL ERROR
Improper calibration, deterioration of reagents (control and standard), sample instability, unstable and inadequate reagent blank, instrument drift or changes in standard materials, contaminated solutions & poorly written standard operating procedure.
Remedy: ________________
Test used for determination: ________________
Systematic Error
Remedy: Stepwise evaluation of the procedure
Test used for determination: Recovery studies, interference, and
Comparison of Methods (COM)
37
# TYPES OF ANALYTICAL ERROR
QUESTION 44: When comparing a potential new test with a comparative method in order to bring a new method into the laboratory, one observes error that is consistently affecting results in one direction. What is this type of error known as?
A. Systematic error
B. Random error
C. Constant systematic error
D. Proportional systematic error
A
38
# TYPES OF ANALYTICAL ERROR
* Refers to the difference between. Target value and Assay value.
* Independent of sample concentration
1. What type of error?
2. Test used for determination?
Contant error
Interference experiment
39
# TYPES OF ANALYTICAL ERROR
* Results in greater deviation from the target value due to higher sample concentration.
* Magnitude of error increases with increasing sample concentration
1. Type of error
2. Test used for determination
1. Proportional Error /Slope/Percent Error
2. Recovery experiment
40
# TYPES OF ANALYTICAL ERROR
* Net or combined effect of random and systematic error, it shows a “worst case” or how far wrong” a test result might be
1. Type of error
2. Test used for determination:
1. Total analytical error
2. Replication and comparison
41
highest frequency occurs with the use of handwritten labels and request forms.
Clerical error
42
QUESTION 45: Which of the following would be necessary to minimize, if not totally avoid occurrence of this error in the laboratory?
ANSWER: Use a thorough checking system; Use of a well-designed worksheet; Presence of a well-trained medical technologists
43
QUESTION 46: One of two controls within a run is above +25 and the other control is below -2s from the mean. What do these results indicate?
A. Poor precision has led to random error (RE)
B. A systematic error (SE) is present
C. Proportional error is present
D. QC material is contaminated
A
44
RECALL: Which of the following refers to 1:3s?
(1) Range between two observations in the same run exceeds 4 SD
(2) Detects imprecision or Systematic Bias
(3) Not Recommended
(4) One observation exceeds 3SD from the target value
A. 3 and 4
B. 2 and 3 (should be random)
C. 1 and 3
D. 1 and 4
A
45
COMMON WESTGARD RULES
aralin mo table bitch
46
QUESTION 47: The term R4S means that:
A. Four consecutive controls are greater than +/- standard deviation from the mean
B. Two controls in the same run are greater than 4s units apart
C. Two consecutive controls in the same run are each greater than +/- 4 from the mean
D. There is a shift the mean for four consecutive controls
B
47
QUESTION 48: Which of the following conditions is cause for rejecting an analytical run?
A. Two consecutive controls greater than 2s above or below the mean
B. Three consecutive controls greater than 1s above the mean
C. Four controls steadily increasing in value but less than t1 s from the mean
D. One control above +1 s and the other below -1 s from the mean
A
48
OTHER WESTGARD RULES
PAARAL THANKS AIDJD
49
QUESTION 50: Which is an indication of error in the analysis detected by a progressive drift of control values in one direction for at least 6 consecutive runs?
* Shift
* Contraction
* Dispersion
* Trend
Trend
50
QUESTION 51: A trend in QC results is most likely caused by:
* Deterioration of the reagent
* Miscalibration of the Instrument
* Improper dilution of standards
* Electronic noise
Deterioration of the reagent
51
When establishing QC limits, which of the following practices is inappropriate?
* Using last month's QC data to determine current target limits
* Exclusion of any QC results greater than +-2s from the mean
* Using control results from all shifts on which the assay is performed
* Using limits determined by reference laboratories using the same method
B
52
QUESTION 52: A batch of test results is out of control. What should you do first?
A. Report the results to the physician first, and then look for the trouble.
B. Follow the "out-of-control" procedure specified for the test method.
C. Repeat the tests with a new lot of standards (calibrators).
D. Repeat the tests with a new lot of reagents.
B. Follow the "out-of-control" procedure specified for the test method.
53
QUESTION 53: Which Westgard multirule applies to a situation where one control point exceeds the mean by + 2 s
and a second control point exceeds the mean by -2 s?
* 12S
* 22S
* 41S
* R4S
R4S
