Quality Management Flashcards
degree of excellence a product or service provides in conformance to the requirements of users or customers and the satisfaction of their needs and expectations.
Quality
an ongoing process that must be persuasive throughout the institution that it becomes the philosophy and culture of the institution
Quality
seeks to improve the quality of products and services through ongoing refinements in response to continuous feedback.
Total Quality Management
comprehensive and structured approach to organizational management.
Total Quality Management
describes the policies, procedures, personnel, standards, laboratory methods, and system operating procedures for tests.
Quality Laboratory Processes (QLP)
procedure for monitoring the process.
Quality Control
helps to prevent, detect, and correct problems.
A good QC system
Quality Control
monitors analytical performance in relation to accuracy and precision
Quality Control
monitors the overall performance includes both analytical as well as customer satisfaction.
Quality Assessment
addresses the pre-analytical, analytical and the post-analytical phase.
Quality Assessment
the outcome of QC and QA
Quality Improvement
it helps to identify the source of the problem.
Quality Improvement
Prerequisite to quality assurance. Establishes and validates process from both analytical quality as well as customer needs.
Quality Planning
Designs processes when one needs to adopt new methods and select new instrumentation.
Quality Planning
helps in designing appropriate QC programs
Quality Planning
represent the requirement that must be achieved to satisfy customer needs.
Quality Goals
for analytical quality the requirement is to provide test results that are correct within the stated limits.
Quality Goals
PDCA Procedure
- recognize an opportunity and plan a change
Plan
PDCA Procedure
- test the change; Carry out a small-scale study
Do
PDCA Procedure
- review the test; Analyze the results and identify what you’ve learned
Check
PDCA Procedure
- take action based on what you learned in the study step
Act
PDCA meaning
Plan, Do, Check, Act
associated with the entire steps, procedures, and considerations in handling a test request.
Pre- analytical Variables
Patient Identification
Test Ordering
Specimen Collection
Specimen Transport
Control of Pre-analytical Variables
Improper container, incorrect preservatives
Phlebotomists must undergo thorough training to understand and follow procedures
Specimen Collection
- Delays in transport and mishandling of specimen
- The authority to reject specimens that arrive in the laboratory in an obviously unsatisfactory condition
Specimen Transfort
Installing automated transport systems such as pneumatic tubes that decrease transport time and labor
Specimen Transfort
The following must be recorded with regards to TAT:
1. Actual time of specimen collection
2. Receipt in the laboratory
3.
Reporting of test results
Turnaround time (TAT)
Specimen Separation and distribution of
aliquots
Centrifuges should be (C&M)
Calibrated and Maintained
Collection tubes, pipettes, stoppers, and aliquot tubes should be tested for ____ by (C and other E)
Contamination
Calcium and other Elements
- Lab must provide well-written, understandable procedures for proper patient preparation, and specimen acquisition
- These procedures must be made available to all medical personnel and outpatients
Patient Preparation
- primarily depend on instrumentation and reagents.
Analytical Variables
- Schedule daily and monthly maintenance
- Routine instrument function/system checks should be detailed, and their performance should be documented
Control of Analytical Variables
- Reagents and kits should be dated when received and opened
- New lots of reagents should be run in parallel with old reagent lots before being used for analys
Control of Analytical Variables
Involve report generation and delivery, interpretation of results and subsequent actions
Post-analytical Variables
- generally, experience fewer and less severe quality problems.
- errors can be serious and significant.
- a lost report or delay in reporting a panic or critical value can jeopardize patient care.
Post-analytical Variables
involves systematic monitoring of analytic processes in order to: detect analytic errors that occur during analysis and prevent the reporting of incorrect patient test results.
Quality Control
Quality Control
- These are specimens analyzed for QC purposes
Control Materials
Quality Control
- substance or material of determined value.
- used to monitor accuracy or precision of test.
Control
Monitors a single laboratory
Internal Quality Control (IQC)
Necessary for the daily monitoring of the precision and accuracy of the analytical method
Internal Quality Control
Compares performance of a laboratory against those of other laboratories
External Quality Assessment
Maintains long term accuracy of analytical methods
External Quality Assessment
evaluates whether a process is operating within expectations relative to some measured values.
Control Charts
as long as the values fall within the upper and lower limits then the process is
“in control”
as long as the values fall within the upper and lower limits then the process is “in control”.
Control Charts
- Shewhart plot
- the most common intra-laboratory quality control chart used in clinical chemistry laboratories
Levey-Jennings Plot
QC concentrations on ___ are centered on targeted mean value
Y-axis
horizontal lines indicate multiples of ___ or for upper and lower acceptability limits
SD
time or QC measurement episodes plotted on
X-axis
he realized that single rule QC protocols ignored previous data and data obtained simultaneously on other control samples
Westgard Control Rules
Dr. James Westgard
increase error detection rates without increasing false rejection rates
Westgard Control Rules
- uses premise that 95.5% of control values should fall within ± 2SD
- commonly applied when two levels of control are used
Westgard Control Rules
uses a combination of decision criteria, or control rules, to decide whether an analytical run is in-control or out-of-control.
Multiple-rule QC
commonly used with a Levey-Jennings chart when the control limits are set as the mean ±2SD
1²s Rule
In the original Westgard multi-rule QC procedure, it is used as a warning rule to trigger careful inspection of the control data by the
following rejection rules.
1²s Rule
1³s Rule
- A run is ____ when a single control measurement exceeds the mean ±3 SD
Rejected
2²s Rule
- when 2 consecutive control measurements exceed the mean ± 2SD
Reject
R4s Rule
- when 1 control measurement in a group exceeds the mean +2SD and another exceeds themean -2SD
Reject
4¹s Rule
- when 4 consecutive control measurements exceed the mean +1SD or the mean -1SD control limit
Reject
10x Rule
- when 10 consecutive control measurements _____ of the mean
Reject
fall on one side
QC values move suddenly upward or downward from the mean and continue the same way
Shift
QC values are distributed on one side of the mean for 6-7 consecutive days
Shift
QC values slowly move up or down from the mean and continue moving the same direction over time
Trend
There is consistent increase or decrease of QC data points over a period of 6-7 days
Trend
1³s or R4s rules:
Random error
2²s, 4¹s, or 10x rules:
Systematic error
more common and usually easier to investigate. It is evidenced by a change in the mean of the control values.
Systematic errors
can be caused by bubbles in reagents and reagent lines, inadequately mixed reagents, unstable temperature and incubation, unstable electrical supply, and individual operator variation in pipetting, timing, and so on.
Random error
devices are a different kind of random error, often called
Flyers
Caused by reagent or machines
Random error
Laboratory working
Systematic error
