Quality Management Flashcards
Public and private pressures to contain healthcare costs are accompanied by pressure to improve quality.
Seemingly contradictory pressures for both (2) require that healthcare organizations adopt new systems for managing quality.
Because of these pressures, other industries implemented_______
cost reduction and quality improvement (Ql)
Total Quality Management (TQM)
The principles and concepts of TQM have been formalized into a quality management process.
The traditional framework for managing quality in a healthcare laboratory has emphasized the establishment of (3)
quality laboratory processes (QLPs)
quality control (QC)
quality assessment (QA).
includes analytical processes and the general policies, practices, and procedures that define how work is done.
QLP - quality laboratory processes
emphasizes statistical control procedures but also includes non-statistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors.
QC - Quality control
as currently applied, is primarily concerned with broader measures and monitors of laboratory performance, such as (4)
QA - quality assessment
(1) turnaround time (TAT)
(2) specimen identification
(3) patient identification
(4) test utility
T or F
Measuring performance by itself improve performance and often does not detect problems in time to prevent negative outcomes.
False!
Quality assurance requires that causes of problems be identified through ____ and eliminated through______, or that____ be able to detect problems early enough to prevent their consequences.
QI
quality planning (CP)
QC
“scientific method”
PDCA cycle (Plan, Do, Check, Act).
____provides the planning step
____establishes standard processes for doing things
________ provide measures for checking how well things are clone
_____provides a mechanism for acting on those reasures.
QP
QLP
QC and QA
QI
The purpose of a _______ is to evaluate the pathophysiologic condition of an individual patient to assist with diagnosis and/or to monitor therapy.
clinical laboratory test
The total error of a result is influenced by the following;
• Biological/physiologic variability within an individual
• Pre-analytic variability in sample collection, transportation, processing, and storage
• Analytic variability in test performance
• Interfering substances such as drugs or retabolic components
Quality control (QC also called______)
statistical process control
process to periodically examine a measurement procedure to verify that it is performing according to preestablished specifications.
Quality control
It involves the systematic monitoring of analytic processes in order to detect analytical errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results.
Quality Control
Quality Control Goals
• Error Detection
• Error Prevention
• Measure performance (Bias, Imprecision, Total Error)
• Monitor performance
• Validate performance
In general, monitoring of ______ methods is performed by assaying stable control materials and comparing their determined values with their expected values.
analytic methods
The expected values are represented by intervals of acceptable values with upper and lower limits, known as________.
control limits
When the expected values are within the_________, the operator can be assured that the analytic method is properly reporting values.
However, when observed values fall outside of the ______, the operator can be notified of possible problems and further analysis of the method can be made before potentially erroneously reporting patient results.
control limits
The principles of statistically analyzing QC were initially applied to the clinical laboratory in the 1950s by________
Levey and Jennings
Specimens analyzed for QC purposes are known as_____
QC materials
These materials must be available in sufficient quantity to last at least a year and aliquoted in stable form.
QC materials
______ should be the same matrix as the specimens actually to be tested.
For example, a glucose assay performed on serum should have ______ that are prepared in serum.
QC materials
_______ should span the clinically important range of the analyte at appropriate decision levels.
For example, sodium QC materials might be tested at 130 and 150 mmol/L, representing cutoff values for hyponatremia and hypernatremia, respectively.
Control material concentrations
QC for general chemistry assays generally use_____ levels of control, while immunoassays commonly use____.
two
three
T or F
Today, laboratories more often purchase control materials from companies that manufacture products for QC, instead of preparing the materials themselves.
True
QC materials are often ______ for stability and can be reconstituted in specific diluents or matrices representing urine, blood, or CSF.
lyophilized (dehydrated to powder)
give expected target ranges, often including the mean and SD using common analytic methods.
Assayed materials
these products are more expensive because of the additional characterization, they allow another external check of method accuracy.
Assayed materials
Because most commercially prepared control materials are lyophilized and require reconstitution before use, the_____ should be carefully added and mixed.
Incomplete mixing yields a partition of supernatant liquid and underlying sediment and will result in______ control values.
diluent
incorrect
the reconstituted material will be more _______ than the actual patient specimen.
turbid (cloudy)
_____ do not require reconstitution but may behave differently from patient specimens in some analytic systems.
It is important to carefully evaluate these ______ with any new instrument system.
Stabilized frozen controls
A common method to assess the determination of control materials over time is by the use of a______
Levey Jennings control chart.
_______ graphically represent the observed values of a control material over time in the context of the upper and lower control limits.
Control charts
When the observed value falls with the control limits, it can be interpreted that the method is performed adequately. Points falling outside the control limits may suggest that problems may be developing.
Control limits are expressed as the________ (formula)
mean +/-SD
The______ system in the clinical laboratory is used to monitor the analytic variations that can occur.
QC
The QC program can be thought of as a three-stage process:
- Establishing allowable statistical limits of variation for each analytic method
- Using these limits as criteria for evaluating the QC data generated for each test
- Taking action to remedy errors when indicated
