quality assessment Flashcards
relies heavily on quantitative
statistical methods that focus on the final product as
defined by the standards set by the producer
quality control
developed out of the limitations
of the QC approach and defined quality in health
care institutions by the success of the total
organization, not just individual components of the
system in achieving the goals of patient care.
quality assurance
activity of the management function that determine the quality policy
quality management
organizational structures, procedures, processes, and resources needed to implement quality management
quality system
planned, systematic activities implemented within the quality system to provide confidence that requirements for quality will be fulfilled
quality assurance
operational techniques and activities used to fulfill the requirements for quality
quality control
To ensure that quality laboratory services are
provided, every laboratory should strive to obtain
modern equipment, to hire well-trained staff, to
ensure a well-designed and safe physical
environment, and to create a good management
team
quality assessment and improvement
ultimately dispels the
concept of “good enough” and promotes one of “it
can always be done better”.
Quality Systems Management
Systems approach that focuses on teams,
processes, statistics, and delivery of
services/products that meet or exceed
customer expectations.
total quality management
An element of TQM that strives to
continually improve practices and not just
meet established quality standards
Continuous Quality Improvement (CQI)
Continually look for ways to reduce errors
(“defect prevention”) by empowering
employees to assist in solving problems
and getting them to understand their
integral role within the greater system
(“universal responsibility”)
total quality management
Process improvement program that is a
hands-on process with the single mantra of
“improvement”: improved performance,
improved quality, improved bottom line,
improved customer satisfaction, improved
employee satisfaction.
six sigma
Ultimately designed to reduce waste
(non-valued activities), which means to
reduce cost by identifying daily work
activities that do not directly add to the
delivery of laboratory services in the most
efficient or cost-effective ways.
lean
quality is free, poor quality is
expensive
philip crosby
Source of most of the concepts and
methods contained in the TQM mode
W. edwards deming
do thing right the first time
philip crosby
Established the concept that quality is a
continuous improvement process that
requires a manager’s active pursuit in
reaching and setting goals for improvement.
joseph duran
Frequently referred to as Evangelist of
quality management
philip crosby
Applied Shewhart’s multirule system to
the evaluation of quality control data in the
medical laboratory.
james westgard
nearness or closeness of a result to the
actual value of the analyte when performing a test
accuracy
used to describe and define the
items that are being studied at a particular time
data population
ability of an analytical method to give
repeated results/reproduces a value
precision
- it include Gaussian Curve,
Cumulative Sum Graph (CUSUM), Youden/Twin
Plot, Shewhart Levey-Jennings Chart, Westgard
Control Rules
quality control charts
statistical tool used to measure systematic
error/accuracy
mean
statistical tool used to measure
precision or the dispersion of values around the
mean
standard deviation
- statistical tool that allows
comparison and check on the precision and
variability of each method
coefficient of variation
– may occur by chance at any time
and place within the testing or service process
random error
– error that influences
observations consistently in one direction
systematic error
formed by control values that either
increase or decrease for six consecutive days
trend
formed by control values that distribute
themselves on one side or either side of the mean
for six consecutive days
shift
main cause is deterioration of reagents
trend
main cause is improper calibration of the
instrument
shift
refers to all the activities that take place
before testing, such as test ordering and sample
collection.
preanalysis
stage consists of the laboratory
activities that actually produce a result, such as
running a sample on an automated analyzer.
analysis
comprises patient reporting and
result interpretation. Collectively, all of the
interrelated laboratory steps in the testing process
describe its workflow
post analysis
3 categories of the testing process:
- Testing phase
- Role
- Laboratory technology
The guidance and recommendations given as
minimum requirements pertaining to laboratories of
all biosafety levels are directed at microorganisms in
Risk Groups 1–4.
Laboratory Design
In designing a laboratory and assigning certain types
of work to it, special attention should be paid to
conditions that are known to pose safety problems.
BIOSAFETY LEVEL 1
- Formation of aerosols
- Work with large volumes or high
concentrations of microorganisms - Overcrowding and too much equipment
- Infestation with rodents and arthropods
- Unauthorized entrance
- Workflow: use of specific samples and
reagents
biosafety level 1
