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