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
