quality assurance and lab design Flashcards
(25 cards)
quality assurance vs quality control
quality assurance:
- preventing mistakes
- includes planning, procedures and systems (make sure everyth in lab is done correctly and consistency)
quality control:
- finding and fixing mistakes
- testing and checking to make sure the results are accurate and reliable
QA = Do things right the first time (focus on prevention)
QC = Check if things were done right (focus on detection)
it relies heavily on quantitative statistical methods that focuses on the final product as defined by the standards set by the producer
quality control
it defined quality in healthcare institutions by the success of the total organization, not just individual components of the system in achieving the goals of patient care
quality assurance
what are the building blocks of quality
quality system:
- organizational structure, procedures, processes and resources needed to implement quality management
quality assurance:
- planned, systematic activities implemented within the quality system to provide confidence that requirements for quality will be fulfilled
quality control:
- operational techniques and activities used to fulfill the requirements for quality
it ultimately dispels the concept of “good enough” and promotes one of “it can alw be better”
quality system management
[QSM = continuous improvement
goal is to deliver reliable results and make the lab better over time.]
what are the standard approached to quality leadership and management
- total quality management (TQM)
- system approach that focuses on teams, processes, statistics and delivery of services that meet or exceed customers
[team-based approach where everyone in the organization works together to improve quality = deliver services that meet or go beyond] - continuous quality improvement (CQI)
- an element of TQM
- strives to continuously improve practices
-not js meet established quality standards
[part of TQM, but with a focus on never stopping.
Keep improving everything, all the time—even if it’s already good.] - six sigma
- hands-on process
- single mantra of improvement
[hands-on method that uses data and step-by-step improvement.
focuses on reducing errors and making processes as perfect as possible.]
4.lean
- reduce waste = reduce cost
[do more with less—faster, cheaper, better.]
TQM = Everyone works together for better quality
CQI = Keep improving continuously
Six Sigma = Reduce mistakes using data
Lean = Cut waste to save time and money
he is frequently referred to as Evangelist of quality management
Philip Crosby
- preach the need forquality practices in the book Quality is Free
- he propounded that:
quality is free, poor quality is expensive
do thing right the first time
0 defects is the only legitimate goal of quality program
he is credited w providing the japenese with the info and training that brough them to their position as the world’s leader in production of quality products
W. Edwards Deming
- source of most of the concepts and methods contained in the TQM model
he established the concept that quality is a continuous improvement process that requires manager’s active pursuit in reaching and setting goals for improvement
Joseph Duran
he applied the Scewhart’s multiple system to the evaluation of quality control data in the medical lab
James Westgard
nearness or closeness of a result to the actual value of the analyte when performing a test (validity)
accuracy
ability of an analytical method to give repeated results/ reproduces a value (reliability/ reproductivity)
precision
accuracy vs precision
Accuracy means how close your result is to the correct or true value.
Example:
If the correct weight of a sample is 5g and your scale says 5g, your result is accurate.
Precision means how consistent your results are, even if they’re not correct.
Example:
If you weigh the same sample 3 times and get 4.8g, 4.8g, 4.8g, your results are precise (because they’re the same),
but not accurate (because the correct value is 5g).
used to describe and define the items that are being studied at a particular time
data population
control charts used to plot quality control values against preciously set limits to determine if the procedures is in or out of control
levy jennings chart
it is used to demonstrate and compare the performance of a lab on paired samples w other lab using common control lots or survey materials
youden plot
it is commonly referred to in the lab as the Westgard’s rule, has formalized the application of multirule techniques to the medical lab
multirule analysis
statistical tool used to measure systematic error/ accuracy
mean
statistical tool used to measure precision or dispersion of values around the mean
standard deviatoon
statistical tool that allowed comparison and check on the precision and variability of each method
COV
random error vs systematic error
random error:
- any time and place within the testing or service process
- affects the precision of a test
systematic error:
- error that influences observations consistently in one direction
- inaccurate results that are consistently high or low
[Random Error
- Happens by chance, varies
- A tech makes a small mistake once
Systematic Error
- Always wrong the same way
- A machine is always off by 2%]
errors which can be observed on LJ charts
trend:
- formed by control values that either increase or decreased for 6 consecutive days
shift:
- formed by control values that distribute themselves on one side or either side of the mean for 6 consecutive days
what are the lab workflow
3 phases:
- pre-analysis
refers to all the activities that take place before testing
- analysis
actually produce a resuly - post-analysis
interpretation
3 categories of testing process
testing phse
role
lab technology
