Outcome 1 Flashcards
(112 cards)
1
Q
Describe why learning quality concepts are important in the clinical laboratory.
A
To provide high levels of service, specifically patient care.
2
Q
Laboratory Quality
A
The accuracy, reliability, and timeliness of the reported test results.
3
Q
Quality Assurance
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Includes all the actions a laboratory takes to ensure quality results.
4
Q
Quality Control
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The control of the process of assaying patient samples.
5
Q
Quality
A
Providing consistent services that meet or exceed the needs of the customers (patients).
6
Q
Benchmark
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the standard of excellence or performance level against which the process is measured
7
Q
Quality Improvement
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The activity associated with improving the lab’s ability to meet quality standards.
8
Q
Accreditation
A
Provides a professional judgment about the quality of the facility, and encourages continuous improvement. It also provides a good indication to the public that each accredited facility is capable of functioning at the required level of competence.
9
Q
Frederick Winslow Taylor
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established an efficiency movement to include standardization and improved practices.
10
Q
Henry ford and Karl Friedrich Benz:
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Improved assembly line processes for car manufacturing plants.
11
Q
Walter A. Shewart
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Introduced statistical methods for quality control in the 1920s.
12
Q
W. Edwards Deming
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Established a management philosophy in the 1950s which moved japan from a country of producing poor-quality materials to one of top-quality products. This was accomplished by changing management attitudes and the adoption of 14 points.
13
Q
Arman Feigenbaum
A
Devised the concept of total quality management and established the intellectual framework for quality as a discipline worthy of senior management’s attention.
14
Q
Kaoru Ishikawa
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Established the fishbone or cause and effect diagrams which expanded on concepts of Deming and Juran.
15
Q
Joseph Juran
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Believed human relations problems were the ones to isolate and resolve. Pareto principle.
16
Q
Philip Crosby
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Began the development of zero defects concepts which must be set by management and emulated by employees.
17
Q
International Organization for Standardization (ISO)
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ISO is an international standard-setting body, and is the largest developer and publisher of international standards that are applicable to many kinds of organizations including clinical and public health laboratories.
18
Q
Clinical and Laboratory Standards Institute (CLSI)
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CLSI is a global non-profit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. Created the QSE model.
19
Q
World Health Organization (WHO)
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WHO creates standards for disease-specific diagnostic labs. Also makes recommendations for best practices in the management of diseases.
20
Q
Clinical Laboratory Improvement Amendments (CLIA)
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The goal of CLIA is to ensure quality in lab testing.
21
Q
Health Technology Assessment
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Involves technical performance, safety, clinical effectiveness, cost, organizational impact, social consequences and legal/ethical aspects of the application of health technology. Assessments occur through studies.
22
Q
Evidence-based medicine
A
Scientific evidence is used to evaluate the efficiency of interventions. Has five critical steps:
The conversion of clinical problems into answerable questions.
Efficient search for the best evidence to answer the questions.
Critical evaluation of the evidence.
Application of the evaluations in clinical practice.
Evaluation of the ensuing clinical practice.
23
Q
Clinical practice guidelines
A
Statements that exist to assist HCW with patient decisions. Focuses on the health of the population, not the individual.
24
Q
Preexamination phase
A
Everything up to the actual testing of the specimen. Ensures quality in everything that precedes testing. The lab is responsible for ensuring all actions performed by non-lab staff are done correctly.
25
Examination phase
The phase where actual patient testing occurs. Calibration and QC are part of this phase
26
Postexmaination phase
Anything that occurs after testing, such as releasing results, and specimen storage/disposal. The use of critical ranges, delta flags, and limit checks is done in this phase.
27
Discuss the impact of test appropriateness/utilization and TAT on quality patient care.
Results that are received in an untimely manner can compromise the patient's treatment, and therefore general health.
28
Discuss the impact of identification and preparation of the patient on the quality of test results.
Identification is critical as collecting/testing a specimen from a different patient can have critical effects.
Preparation is needed to ensure quality specimens are collected. This prevents recollections, delays, and poor patient results.
29
List the12 QSEs.
- Organization
Mission and vision statement from management to ensure QSE.
- Personnel
Having clearly defined job qualifications, description, selection processes, orientation, and training.
- Equipment
Equipment must meet expectations.
Processes for maintaining, and troubleshooting.
- Purchasing and inventory
Identification of critical supplies
- Process control
All processes must be documented in an easy-to-find and understandable manner.
- Documents and Records
Documents are SOPs, worksheets, and results.
- Information systems
Management of information between services within the organization, and external agencies.
- Occurrence Management
Capture and analyze information to identify the systematic problem, and how to solve the problem.
- Assessment
Audits/ accreditation
- Process improvement
Need for continuous improvement
- Service and satisfaction
Meeting customer expectations
Feedback
- Facilities and safety
A safe work environment for HCWs, patients, and visitors.
30
Define QSEs
Quality Management System Essentials
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Standards
Substances of known characteristics that are used for calibration.
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Controls
substances with known characteristics that are used to verify accuracy and precision when assaying unknowns.
33
Precision
Reproducibility
34
Accuracy
The degree of correctness of closeness a measurement comes to the true value.
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Reliability
Degree of accuracy and precision over an extended period of time.
36
Specificity
The ability to measure one component without interference by other components. Uses negative controls.
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Sensitivity
The ability to measure a small amount of a component. Uses positive controls.
38
Error
Inexactness of a measurement.
39
Systematic Errors
A change in accuracy, affect all results of an assay. Often result due to personal bias (ex. Poor technique pipetting)
40
Random Errors
Associated with a change in precision. Often due to carelessness.
41
Reference Interval
provides the caregiver with what is expected for the population they are serving.
42
Variables
Observations about the methods being evaluated.
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Qualitative
Variables that refer to descriptions.
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Quantitative
Variables that refer to a numerical observation.
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Semi-Quantitative
Variables that do not measure an exact quantity (ranges).
46
Discrete Variables
Observations that can be counted.
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Continuous Variables
Observations for which any value within a particular range is possible (age).
48
Population
A large body of data that does not have to be finite.
49
Central Tendency
The clustering of data points or variables.
50
Mean
Average of values.
51
Median
The middle number of a set of values arranges in increasing numerical order.
52
Mode
The value that occurs most frequently.
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Normal distribution
The median, mean, and mode are the same.
54
Standard Deviation
A measure of variance that is often used in the clinical lab.
55
Coefficient of Variation (CV)
the standard deviation expressed as a percentage of the mean. CV= (S/X) 100%.
56
Discuss the use of frequency distribution curves and histograms.
These are graphical representations of statistical data. They are important in determining reference intervals for patient results, and control ranges for quality control.
× ± 1s includes 68% of all values
× ± 2s includes 95 % of all values – 95% confidence limits
× ± 3s includes 99.7% of all values
57
Skewed Distributions
Non-symmetrical. The mean, median, and mode are not identical. Skewing depends on if values are to the left or right of the mode.
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Bimodal Distributions
Show the occurrence of two populations (seen as two curves).
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Process Control
This entails identifying activities critical to the quality of the process output and either designing the process to prevent incorrect performance or including a means to detect a problem. Uses validation and verification.
60
Internal Control
A set of procedures for continuously assessing lab work and results.
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Validation
A system validated by the manufacturer or method developer using formal study protocols.
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Verification
When the lab ensures the performance of an examination method that has been validated by the manufacturer.
63
Discuss the general components for implementing and maintaining a QC program.
Establishing SOPs
Training staff
Ensuring complete documentation
Reviewing QC data
64
Discuss control material including types and criteria for selection.
Controls are substances of known values that are used to check the sensitivity or specificity of an assay. They are tested alongside patient samples ensuring the system has been validated to produce reliable results.
Selection is based on:
Cost
Specimen (control should be as close to the specimen as possible)
Storage
Environment
65
In-house Controls
Controls that are made within the lab. Cheap, but take time.
66
Commercial Controls
Controls that are purchased by the lab. Expensive, but easily used.
67
Blind Duplicate Controls
Control of the lab's process, a patient sample is assayed, then divided, relabelled, and ran again. Both analyses should be identical or similar if the lab has an accurate and precise process.
68
Built-in controls
Controls that are integrated into the test system (control line on pregnancy tests) - only monitor a portion of the test phase (such as adequate sample volume).
69
Microbiology test cultures:
Reference strains of microorganisms are purchased from ATCC (American type culture collection). These are used to verify stains, reagents, and media.
70
Microbiology media
Media is evaluated for: sterility, appearance, ability to support the growth of microorganisms, and ability to yield appropriate biochemical results.
71
Stains
Ensures stains perform as expected. Stains are checked routinely with positive and negative controls.
72
Outline the general steps required for setting up a QC program for quantitative procedures.
Establish policies and procedures
Assign responsibility for training and monitoring
Training of staff
Selection of QC material
Establishing a control range
Develop graphs to plot and monitor control values
Taking corrective action
Maintain records of QC results and action logs
73
How many levels of controls should be used for quantitative analysis.
2-3 controls could be used, this ensures the method is capable of analyzing very high or low values of the analyte.
74
Discuss the monitoring system for quantitative control systems including
When control material is evaluated, a minimum of 20-30 values should be collected.
The manufacturer's instructions should be followed.
Every tech who will be involved in QC must be a part of the process.
Data is plotted, and gaussian distribution is looked for.
SD is calculated and results outside of +/- 3SD are thrown out (outliers)
Recalculate the mean and SD.
Establish control range as the mean +/- 2SD.
75
Discuss some causes and troubleshooting procedures for out-of-control values for quantitative analysis.
Degradation of reagents or QC material
Operator error
Failure to follow manufacturers' instructions
Failure to follow SOP
Equipment failure
Calibration error
Check SOP for troubleshooting procedures.
76
Describe the use and monitoring capabilities of quality control charts.
LJ charts can be useful for determining whether the method is in control and if any out-of-control data points are random or systematic errors. Techs can make decisions about the correctness of the patient results based on the control values' ability to remain within the control range. Imprecision, trends and shifts can be identified.
77
Describe the use and interpretation of multi-rule systems or Westgard rules.
Westgard rules distinguish between random and systematic error, and can help to determine what/if corrective action should be made.
78
Describe the mean of normals.
The average of the patient’s results is calculated. This is done on an ongoing basis to detect a change in precision or to detect systematic error. The mean target constant and the daily mean clause should not differ from the target value by more than 3% and the CV should be less than 1.5%.
79
Method Evaluation
The new method must be evaluated for both precision and accuracy as well as for its ability to correctly diagnose disease. Individual labs must verify that the claims can be met within the laboratory’s own environment, using its own equipment and personnel.
80
Linearity Checks
Preliminary checks on the accuracy of the new method. This procedure involves assaying a series of increasing or decreasing concentrations of an analyte using the new method. The data is plotted and examined. If the method is linear it should have a 45° angle, if the method is not linear the data will be scattered.
81
Tests for Significance
Used to evaluate the precision and accuracy of the new method.
82
Significance Level
New methods brought into the lab must be evaluated for its reliability against the old method or against a reference method. In order to compare the two methods several samples are split, and tested using the new method, and the reference method. We use the 95% confidence limits, and eliminate the top and bottom 2.5% - this 5% is the time we will have an incorrect result as is known as the significance level. This allows us to make decisions as to whether or not the two sets of data are the same, and how similar the methods are.
83
F-Test
Used to compare the precision of a new method to the reference method. Compares the variance of the two methods and judges if the variance are essentially the same.
84
T-Test
Used to compare the accuracy of a new method or instrument to a reference method or to the old method, by comparing the mean.
85
Correlation Coefficient
This test is used to compare the results of one method to those obtained by a second method. It determines the relationship between any two items, provided the items have a numerical value.
86
Diagnostic Method Evaluation
The results of lab tests are matched to the presence or absence of disease in the patient and a new judgment is made about the ability of a test to reflect true patient status.
87
Diagnostic Specificity
indicates the assay's ability to only detect the analyte in question. (TN/(TN+FP))x100
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Diagnostic Sensitivity
Indicates the assay's ability to detect low values. (TP/(TP+FN))x100
89
Predictive Value
Shows the assay's ability to correctly diagnose disease in the population. (TP/(TP+FP))x100
90
Discuss the following in regard to the reference interval: Purpose and Use
Used to evaluate patient results to determine if the patient is healthy or in fact clinical diseased. Determined by finding +/-2SD.
91
Discuss the following in regard to the reference interval: Processes involved in the determination.
Sampling the population: The larger the sample size the less variation that is introduced into the calculation of the range - ideally 100-150 values are obtained.
Laboratory Variation: Different labs have different methods, equipment and day to day variation.
92
Discuss the following in regard to the reference interval: processes used to calculate?
Frequency curve is created, and gaussian distribution is looked for.
SD is determined
Outliers are thrown out
A new mean and SD are calculated and a reference interval of +/- 2SD is made.
93
When should the reference interval be re-evaluated?
A step in a method is modified, removed, or added.
A method becomes automated.
The population changes significantly.
A method is changed entirely.
94
Clinical correlation
When a check is done of the patient's test result with the clinical diagnosis.
95
Correlation with results of other lab tests
When the result of a single test is possible, but when looked at in conjunction with other results it becomes impossible.
96
Delta checks
When a patient has had the same lab tests done on multiple occasions, delta checks can be done to see if they fall within the limit allowed for normal changes. Usually monitored by LIS, and if there is a significant change in lab results the LIS triggers a delta flag.
97
Limit checks
Occurs when patient results are beyond the reference interval or appear incompatible with life (critical results).
98
Test completion checks
Verifies if all tests ordered are completed. LIS monitored, lists of incomplete tests are created.
99
Reporting mechanisms
Reporting of results to physicians has a direct outcome on the care of the patient.
100
Reflexive testing
When the result of one test automatically triggers another test (positive Covid PCR, triggers Covid Variant)
101
Risk
The likelihood that a problem will occur.
102
Risk assessment
Serves two major functions.
1. Critical examination of all steps in a process.
2. Using the steps in the process to highlight potential risks and put measures in place to control them.
103
Risk management
A process that identifies and assess risks, and their anticipated frequency. Solutions are found, and monitored for effectiveness.
104
List the steps involved in a risk management plan.
1. Gather all required information
2. Identify and assess risks, and identify mitigation options.
3. Make a plan to minimize risk, and have it include all the actions required to minimize the risk.
4. The plan is implemented and monitored for effectiveness. Any errors are corrected (CAPA).
105
Explain why risk assessment is important.
They give the lab the ability to assess and prioritize the risks, and determine what level of risk is acceptable.
106
FMEA
Failure modes and effects analysis.
Discovering possible sources of failure, determining the probability and consequences of each failure, and outlining control measures to detect and eliminate such failures.
107
FRACAS
Failure reporting and corrective action system.
A system used to look at failures and prevent them from occurring again.
108
Explain the importance of low-probability and high-impact risks.
These are difficult to manage as they occur rarely, and have the potential significant impact. Typically can only be prepared for by simulations. (example. Earthquake).
109
CAPA
Corrective and Preventive Action.
110
Define Point of Care Testing
This testing occurs at the patient's bedside.
111
Describe the role of the laboratory in ensuring quality point-of-care testing is performed.
The lab is responsible for ensuring that training of non-lab staff running the test is done, and that the tests are performed with quality in mind. Lab plays a role in every level of POCT (POCT director: Pathologist, Test Site Manager: Supervisor, POCT Coordinator: MLT, Testing personnel: Person who performs the testing).
112
List the advantages and disadvantages of POCT.
Advantages:
- Reduced TAT
- No patient specimen transport
- Reduced risk of pre-examination
- Reduced amount of sample volume.
Disadvantages:
- Not standardized between locations
- LIS isn't connected to POCT instruments
- Training of staff
- Improper collection
