LAB MAN - L8: QUALITY ASSURANCE
ACCURACY
- Closeness of a result to the actual value of an analyte when performing a test - "hitting the bull's eye"
SCATTER DIAGRAMS
- This method is used to show the relationship between one variable and another - Advantage: all data points, not just the summary statistical indexes, are plotted on the graph.
Perceived Quality
- relates to the customer's subjective opinion of the product's or company's reputation
CRITICAL-CARE PATHWAYS (CARE PATHS)
-Also called SIMPLE CARE PATHS -this plan incorporates all the resources of the health care system into the delivery
MULTIRULE ANALYSIS
-Commonly referred to as "WESTGARD RULES" -The 6 rules proposed by Westgard and Barry for accepting or rejecting a control run are based on the expected Gaussian distribution of sample values.
WALTER SHEWHART
-Father of Statistical Quality Control -His work served as a basis for the multirule-based Westgard rules
CAUSE-AND-EFFECT DIAGRAMS
-Other names: Ishikawa diagrams, fishbone diagrams -Used to identify the possible causes or contributing factors of problems or quality defects
RUN CHARTS
-Other names: trend charts -Line graph used to display data over a period of time. Show patterns of performance.
WESTGARD MULTIRULE ANALYSIS
-Two levels of control at different concentrations will be more efficient in monitoring the method when evaluated statistically -By running and evaluating the results of two controls together, trends and shifts can be detected much earlier
BASIC STATISTICAL GRAPHS
These are used to illustrate the comparative size of different components or factors, most other graphical display techniques are already modifications of these three methods
DISPERSION
It is a sign of loss of precision and may be caused by inconsistency in such areas as a malfunctioning automatic dispenser or variations in technique by testing personnel.
Durability
Measure of product life: Amount of time os use one obtains from a product before it physically deteriorates
COEFFICIENT OF VARIANCE
This procedure allows the comparison and check on the precision and variability of each method.
ARMAND FEIGENBAUM
Total Quality Management
YOUDEN PLOT
Used to demonstrate and compare the performance of a laboratory on paired samples with other laboratories using common control lots or survey material.
DATA POPULATION
Used to describe and define the items that are being studied
CONTROL CHARTS
Used to plot control measurements against standards (i.e upper and lower limits) used to identify whether a process is in or out of control.
STANDARD DEVIATION
Measurement of precision, or the tendency of the values in each population to cluster, center, or scatter around the mean
QUALITY MONITORING AND ASSESSMENT TOOLS
The precise techniques and mechanisms of quality control are familiar to every technical professional in the laboratory
HISTOGRAMS
does not contain any gaps while the frequency polygons are the very familiar line graphs that give the frequency distribution its descriptive name-the bell curve.
Bar graphs
helpful in presenting comparative inter-population and intra-population factors
RANDOM
in a manner that ensures that each unit of the population has an equal
Decision-making Based on Facts
information and data gathered from patients
Licensure and Accreditation programs
involve onsite inspections
Performance
is a much easier concept to define and measure than the elusive "Quality
P
is usually expressed in statistical notation as a decimal (0.0 to 1.0) according to the likelihood of an event occurring.
Nearer to zero(0)
less likely to occur
JCAHO
maintain standards for the laboratory and also includes a designated member of their site visit team to review the laboratory
TRENDS
marked by a systematic drift in one direction away from the established mean. May be detected by 4s or 10x Westgard rule failures
RANDOM ERRORS
may occur at any time and place within the testing or service process. Indicative of imprecision in an analytical problems
Communication
most important among everything as it allows understanding, comprehension, and connection between employees and patients.
● N
number of observations (individuals, measurements or values) that make up the sample used for calculating statistical indexes.
SYSTEMATIC ERRORS
occur in a consistent direction or pattern (problems of inaccuracy).
AABB and CAP
professional lab org. They provide extensive educational and resource material about their review processes, including accreditation standards and inspection guidelines.
quality control
refers specifically to the activities directed toward monitoring the individual elements of care
Integrated System
required in a hospital set-up
STATISTICALBIAS
set of numbers that do not truly reflect the characteristics of the whole population, which may be either circumstantial or intentional.
Diversity
someone of a "minority" is invited to become a permanent and contributing part of a team that includes a wide range of represented groups.
Class Interval
statistical term for each part of the population
Line graphs
that give the frequency distribution its descriptive name, "bell curve"
OUTLIER
the exclusion of a number that does not appear to belong in a group of data.
TQM
the management philosophy and system that promotes positive organizational change and effective cultural environment for continuous improvement of all aspects of the organization
Nearer to one (1)
the more likely the event is about to happen
-American Association of Blood Banks -College of American Pathologists
two professional laboratory organizations that have been leaders in offering inspection and accreditation programs. Both provide extensive educational and resource material about their review processes including and inspection guidelines
"A delighted customer"
ultimate definition of quality
PEER REVIEW ORGANIZATION
under TEFRA this program moved from a local orientation to a single contracted PRO association responsible for an entire state or region
Instrument Performance Matrix
used by Coulter Hematology Reports for its interlaboratory QA program is an example of a technique that has replaced Youden Plot
Proficiency surveys
which blind specimens are sent by an external agency for analysis and comparison with other labs.
JOSEPH JURAN
● Quality is a continuous improvement process that requires managers' active pursuit in reaching and setting goals for improvement. ●Pareto Principle or 80/20 rule - managers should focus their time and efforts on identifying and solving 20%
QUALITY ASSURANCE
●A program in which the overall activities conducted by the institution are directed toward assuring the quality of the products and services provided.
MANAGEMENT BY OBJECTIVES
●A program that embodies all the concepts in the management process
JAMES O. WESTGARD
●Applied Shewhart's multirule system to the evaluation of the quality control data in the laboratory, particularly in the multi ranged controls used in clinical chemistry
PHILIP CROSBY
●Evangelist of QM ●"Quality is free. Poor quality is expensive" ●Do things right the first time ●"Zero defects" is the only legitimate goal of a quality program.
W. EDWARDS DEMING
●Provided the Japanese with te information and training that brought them to their position as the world's leader in the production of quality products
communication
The core of management by objectives
INSTITUTIONAL PROGRAMS
The laboratory's increasing participation in these institutional programs is reflected in the JCAHO's QA&I and CPI programs.
Aesthetics
The look, feel, sound, taste or smell of a product
POPULATION SAMPLE
A part of a population that is used to analyze the characteristics of that population
GAUSSIAN DISTRIBUTION DISPLAYS
A relative frequency scale represents the vertical axis of the graph; the values of the variable being studied are located on the horizontal axis.
Quality Control
A set of activities for ensuring quality in products, focused on identifying defects in the products produced
Quality Assurance
A set of activities for ensuring quality in the process by which products are developed
ERROR
Accept/Reject and Problem/ No Problem Decisions
MEAN
Arithmetic average for all the data contained in a sample population
Corrective Tool
As a tool, What is Quality Control
Managerial tool
As a tool, what is Quality Assurance
KAORI ISHIKAWA
Cause-and-effect diagram
Features
Characteristics that supplement basic product performance features
CIRCLE/PIE CHARTS
Circular figures with areas marked off either shaded or sketched according to the percentage of each component compared to the entire whole
TREND
Consistent increase or decrease of QC data points over a period of 6-7 days.
LEVEY-JENNINGS CHART
Control charts used to plot QC values against previously set limits to determine if a procedure is out of control
TOKENISM
Defined as the practice of doing something such as hiring a person who belongs to a minority group, only to prevent criticism and give the appearance that people are treated fairly.
Conformance
Degree to which a product's design & operating characteristics meet pre-established standards.
PRECISION
Determined by how well the procedure reproduces a value
XTERNAL QUALITYASSESSMENT PROGRAMS
Focuses on laboratory-based programs and the other plans as part of the indicators of the overall quality performance of the institution
Continuous Performance Improvement
Focuses on the success of the organization in designing and meeting set goals and objectives
QUALITY ASSESSMENT AND IMPROVEMENT
Incorporates the concepts of quality assurance and TQM/CQI, especially the idea that quality assurance is a continuous process of improving the system, not just an endpoint measurement, and that it requires the direct support and active participation of the leadership of the organization
UTILIZATION REVIEW
Is a utilisation plan in 1996. Local physician committees were required to review the medical necessity of care, with the main focus on reducing the patient's length of stay in hospital.
CONSUELA KNOX
Pointed out that intent is important in deciding whether or not a company is engaging in tokenism
Performance
Primary operating characteristics of a product
Reliability
Probability of a product's success within a specific period of time
PROFICIENCYSURVEYS
Programs that allow a laboratory to compare its performance on a common sample with a group of peers based on size (number of beds, specimen volume) and methodology (instrument, reagent).
THE PHILOSOPHY OF QUALITY
The attitude of the people toward their work, themselves, the organization, and their customers is reflected in how they treat each other, view their shared interest in achieving common goals, and view their professionalism in the delivery of their product or service.
FLOW CHARTS
Serve the same purpose in quality management programs by identifying and describing the exact sequence of work tasks and checking out ways for improvement by modelling work routes.
Serviceability
Speed, courtesy, ease of use, maintenance and service
STORYBOARDS
Technique of using a pictorial sequence on a flip chart or other visual aid to "tell a story" of a quality management project
PARETO CHARTS
Term used in a bar chart that is designed to illustrate the classical Pareto principle, which states that 80% of all problems can be attributed to 20% of the possible causes.
CUSTOMER, PRODUCER, SUPPLIER,
What are the 3 roles of the total enterprise
Proactive quality process
What is the focus of quality assurance
Reactive process
What is the focus of quality control
Process oriented
What is the orientation of QA
Product oriented
What is the orientation of QC
SHIFTS
a sudden switch of data points to another area of the control chart away from the previous mean.
CQI
a systematic approach to the measurement, evaluation, and improvement of the quality of all products and services through the use of disciplined inquiry and teamwork
Employee Involvement
allows the delivery of best quality service to patients
Process Centered
allows the delivery of definitive diagnosis through following a process
PROFICIENCYSURVEYS
are activities by accredited organizations in order to assess the laboratory if they are competent or not.
Line graphs
are particularly useful in plotting and tracking data over a period of time
GAUSSIAN DISTRIBUTION
bell-shaped curve", "normal distribution", "frequency polygon" and "LeveyJennings chart"
SKEWED CURVES
deviations from the symmetrical bell-shaped appearance of a frequency polygon and serve as a signal that the data do not accurately reflect the parameters of the population.
Strategic & Systematic Approach
dealing with patients