MIDTERMS: Quality Management Flashcards
It is widely accepted nowadays that medical decisions are reliant on_______ and to have these values for clinical decision making an individual lab test result must have total error small enough to reflect the biological condition being evaluated.
laboratory results
Determining and maintaining accuracy requires considerable effort and cost.
However, the benefits that we are going to gain from such is much more higher than its cost.
QUALITY MANAGEMENT
Is important to customers.
It can be assessed and monitored.
It can be improved.
QUALITY
Quality’s benefits exceed its_____.
cost
Bahala na mahal ang gasto basta taas ang QUALITY. Why? Para magbalik ang customers and maasahan ka
QUALITY
• every consumer is going to seek for high quality products and high quality services. However, what takes us away from quality is actually the_____.
quantity
Patients are going to select the best healthcare facility based on the_____
quality of services
In the laboratory, our product is the______. Thus, it is important to provide them with accurate, precise, and reliable results in order for them to achieve the right diagnosis.
laboratory result
PRE-ANALYTIC phase
• Patient/Client Preparation Sample
Collection
• Personal Competency Test Evaluations
• Sample Receipt and Accessioning
• Sample Transport
Most critical phase?
Analytic
This is the most crucial phase since this we are going to to the testing of our samples.
ANALYTIC
If the values are already acceptable, we are going to report them to the respective physicians or to the patient itself in the form of giving out laboratory result and of course we are going to keep our records for future retrieval.
So it is very important that in all three phases we are going to assure quality, we ensure the safety both patients and employees, and provide excellent quality service.
Analytic
Analytic phase
Testing
Most often______ is only included in the pre-analytic as well as the post-analytic.
________ is the one who involved in the analytic phase of testing.
physician
Medtech
Most of the analyzer is involved in the_____ phase.
analytic
POST-ANALYTIC
Record keeping
Reporting
+
Access result
Interpret result
Integrate with other clinical info
Clinical action
“Planned and systematic activities to
provide adequate confidence that requirements for quality will be met”
Quality Assurance
Measurement of the broader dimension of quality from the perspective of the end-user (client) - Bishop
Quality assurance
BENEFITS OF LABORATORY QUALITY ASSURANCE
• QA provides evidence of good performance
• Laboratory mistakes are prevented
• Significant improvements in testing performance can be achieved.
• Research findings from the College of American Pathologists, the University of Wiscons, and the Centers for Disease Control and Prevention.
WHY IS QUALITY ASSURANCE OF TESTING IMPORTANT?
Public expects high quality
Defines parameters & quality goals
Evaluation & improvement system
Assures reliability & comparability of results
Cost effective
Even the simplest of testing is not foolproof
QUALITY ASSURANCE MODEL
- Proficiency Testing
- Staff
- Quality Control
Proficiency Testing also known as
EQA
internal or external
-aliquots and reagents are used for
Quality Control
One of the key components in providing quality service to the laboratory is the…
staff or medical technologist
STAFFING COMPONENTS:
• Able to execute responsibilities of director, supervisor, testing personnel
• Appropriate educational credentials
• Appropriate experience
• Receive training
• Competency assessments
is the clinical laboratory involves the systematic monitoring of analytic processes to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results
Quality control
is referring to activities that is involved mainly to measure the errors that is involving the analytical phase of the laboratory process and its ultimate goal is to prevent the reporting of incorrect patient test results mainly to ensure accuracy.
Quality control
A testing designed to assess the
“HEALTH” of an analytical method
Quality control
Having quality control is essential. It enables us to:
Error detection
Error prevention
Measure performance (Bias, imprecision, total error)
Monitor performance
Validate performance
results in lab are used to VALIDATE (confirm) whether the instrument IS operating within pre-defined specifications; concluding that patient test results are reliable.
QC
Arrange..
PHYSICIAN
QC
TREATMENT
PATIENT RESULT
QC
PATIENT RESULT
PHYSICIAN
TREATMENT
HOW DOES BASIC QUALITY CONTROL WORK?
• Run a control sample
• Compare result with expected range of values
• Check to see if the result is right
Is checking if analyzer is producing correct results
QC
Quality control is actually measured by
STATISTICAL APPROACHES/CONCEPTS:
Central Tendency
Range
Standard Deviation (SD)
Coefficient Variation (CV)
Once we have the values, we are going to PLOT THE DATA (PLOTTING DATA)
Levey-Jennings Chart
APPLICATION OF MULTIRULE SYSTEMS
• Westgard Rule
- Measuring or assuring the quality of the procedures in the entire laboratory process from pre-analytical, analytical, and post-analytical
QUALITY ASSURANCE
- Is part of quality assurance
QC
It is part of the pillars of quality assurance along with staff and professional competency
QC
Focused on the analvtical process of laboratory testing
QC
Measuring the entire process
QA
- Ensures that the lab tests are done right
- To ensure that the results produced by the laboratory from the instrument and the method that we use in analyzing samples are accurate
QC
“SETTING” the analyzer to give correct results
Calibration
“CHECKING” if the analyzer is producing correct results
Quality control
Uses calibrators (standards)
> Reagent purchased by the laboratory
Calibration
The instrument’s calibration and other analytical processes
Quality control
Setting the instrument to ZERO - reset the machine
Calibration
Checking if calibration is done right/if instrument is calibrated properly
Quality control
In case there is a problem in calibration, therefore,_____ results are usuallv fluctuating - indicating error (problem in calibrating procedure)
quality control
Calibration
Solution that contains a_____ amount of analyte used to calibrate an assay method
known
Quality control
QC material or solutions used to monitor the_____ (precision and accuracy) of an assay method once it has been calibrated
performance
Run prior to QC manually by the laboratory analyst or automatically by the microprocessors
controlling the instrument
Calibration
Run along-side patient samples and results are calculated from
calibration data as the same manner the patient results are calculated
QC
is actually going to evaluate the type of calibration that was done on the machine
> In case there is a problem in calibration, because __\\results is not good, then therefore = DO NOT
RELEASE THE PATIENT RESULTS - indicates error
Quality control
In case that quality control results are good, means_____ is done right and you are confident that you are giving accurate results
calibration
CRITERIA FOR SELECTION OF
CONTROL MATERIAL
Closely mimic (same matrix)
Stable for prolonged periods (at least a year)
Inexpensive
Available in aliquots convenient for daily use
Include at least 2 levels of controls
Convenient packaging for easy dispensing and storage
= refers to the substance or
base from which the control material is prepared.
MATRIX
• If you are going to purchase 1 vial of control material, it will be aliqouted into small amounts and it is going to be consumable for AT LEAST______
It is important that once it is stored, it will be stable for long periods of time
6 MONTHS
(dehydrated to powder)
control material
LYOPHILIZED
are much more expensive compared to the reagents that you are going to use in your procedure, but despite the expense, it is going to give us/measure the quality of our procedure - we are still benefiting from it despite its cost
Control materials
Levels of control in CC
2
Levels of control in Hema
3
IMMUNOHEMATOLOGY and HEMATOLOGY, have 3
LEVELS OF CONTROLS:
• Normal control
• Abnormally Low Control
• Abnormally High Control
Problems:______
Make sure that right amount of diluent will be added to avoid altering the concentrations of the analvtes present in the control materials
RECONSTITUTION
Usually in the CINICAL CHEMISTRY
AREA, we have_______ FORMS of QC materials
LYOPHILIZED FORMS
TYPES OF CONTROL MATERIALS
Assayed
Unassayed
Homemade
Type of control material
• Target value predetermined
o Verify and use
• More expensive
Assayed
Type of control material
• Target values not predetermined
• Full assay to be established
• Less expensive
Unassayed
Type of control material
• Pooled sera collected in the laboratory
• Full assay, validation needed
“Homemade” or “In-house”
“If______ materials are used, the values stated on the _____ sheets should be used only as guides
assayed
Actual values and standard deviation must be established by____ testing in the laboratory”
serial
T or F
In assays
Every lab should establish their own range
True
“The __________recommends that at least 20 measurements should be made on “separate” days when the measurement system is known to be stable”
Clinical Laboratory Standard Institute
(CLSI)
Describes the closeness of a test value to the actual/target/true value
ACCURACY
Accuracy can be measured 3 ways
Recovery study
Interference study
Comparison of Methods of Study
- in _____ study, you are going to get a small aliquot of a concentrated analyte and add it to a patient sample then you are going to measure the method that you are going to validate or evaluate. It measures how much of an analyte can be detected in the presence of all other compounds in a particular matrix
Recovery Study
- this is able to determine if the specific compounds found in the sample can affect the measuring or the accuracy of the lab test.
Remember that these ____ substances can actually alter the results by scattering light, absorbing light, and sometimes it is going to react with your reagents.
Interference Study
examines the patient sample by the method being evaluated with a reference method or gold standard.
Comparison of Methods of Study
1._____ - by giving a particular concentrated analyte in the patient sample and then measure it
2._______ - add interfering substances and measure the sensitivity of your reference method despite the process of these interfering substances, you are still able to get the accurate result
3._______ - you are going to compare your new method or procedure with the gold standard of that particular test
Recovery Study
Interference Study
Comparison of Methods of Study
• The consistency of a series of test results
• The closeness of agreement between independent test results obtained under prescribed condition
PRECISION
The degree of replication of data
Ability of an analytical method to give repeated results on the same sample that agree with one another
PRECISION
• Refers to the capacity of a method to maintain both accuracy and precision
RELIABILITY
This is actually our basis for making a particular method as a gold standard
Reliability
Capacity to produce the same results on one sample again and again when performed by the
same individual using the
same lot number on the
same instruments
REPEATABILITY/PRACTICABILITY
Capacity of the method to produce the same results on one sample again and again when performed by
different individuals on
different days using
different sets of reagents
REPRODUCIBILITY
is the ability of an analytical method to measure the smallest concentration of the analyte of interest
Sensitivity
is the ability of an analytical method to measure only the analyte of interest
Specificity
is the ability of the test to detect the proportion of individuals with that
disease who test positive with the test
Diagnostic sensitivity
is the ability of the test to detect the proportion of individual without the
disease who test negatively for the disease
Diagnostic specificity
PROFICIENCY TESTING (PT) ALSO KNOWN AS
EXTERNAL QUALITY ASSURANCE (EQA)
• Occurs when central organization sends out challenge specimens for testing
PROFICIENCY TESTING (PT) ALSO KNOWN AS EXTERNAL QUALITY ASSURANCE (EQA)
in parasitology the reference laboratory will be your
research Institute for Tropical Medicine or your RITM
For
example, this serum sample
provided from ______ will be tested for
HEPA and others for HIV as
well as for syphilis
San Lazaro hospital or sent from San
Lazaro hospital
PURPOSE OF EXTERNAL QUALITY ASSURANCE
Early warning-system for problems
Measure of laboratory quality
Valuable benchmarking tool (standardization and traceability)
Indicator of where to direct improvement efforts
Monitor of changes in technology and testing practices (evaluation component)
METHOD EVALUATION
- First we are going to _____ and most often that test method has to be validated
2._____method
(in case you don’t agree with your results it’s either you improve or develop improvements on that particular method or you are going to select another method and do another validation)
- After validating your method and you think that they are also acceptable, you will now be going to______ the method by including it in your routine testing.
- In your______, you are going to test it by running QC
5.______ (monitor performance) if we will have problems with our QC results then we are going to adjust - _______and we will go back to implementation, make it a part of your routine testing. If the QC results are now okay, all the results that is being run by the said method will now be reported
7.______
SVIRQAR
Select testing method
Validate method
implement
routine testing
QC statistics
adjust/maintain procedure
Results reported
• Able to execute responsibilities of director, supervisor, testing personnel
• Appropriate educational credentials
• Appropriate experience
• Receive training
• Competency assessments
STAFFING COMPONENTS
- Ability of analytical method to measure the smallest concentration of the analyte of interest (0.005 > 0.5)
Analytical Sensitivity
- Ability of an analytical method to measure only the analyte of interest (1 test > 2 tests)
Analytical Specificity
- Ability of the test to detect the proportion of individuals with that disease who test positively with the test
Diagnostic Sensitivity
Focuses on true positives
Diagnostic Sensitivity
- Ability of the test to detect the proportion of individual without the disease who test negatively for the disease
Diagnostic Specificity
Focuses on true negatives
Diagnostic Specificity
