Quality Management Flashcards
defined as “coordinated activities to direct and control an organization with regard to quality
Quality Management System
refers specifically to the activities directed toward monitoring the individual elements of care
Quality Control (QC)
a program in which the overall activities conducted by the institution are directed toward assuring the quality of the products and services provided
Quality Assurance (QA)
- A quality management program that includes each component (customer, producer and supplier) in the creation process
- Systems approach that focuses on teams, processes, statistics, and delivery of services/products that meet or exceed customer expectations
Total Quality Management (TQM)
A quality management program that focuses on the success of the organization in designing and achieving its set goals and objectives
Quality Assessment and Improvement (QA&I)
- Relies heavily on quantitative statistical methods that focus on the final product as defined by the standards set by the producer
- Is a system of ensuring accuracy and precision in the laboratory by including quality control reagents in every series of measurements
- Is a process of ensuring that analytical results are correct by testing known samples that resembles patient sample
- It involves the process of monitoring the characteristics of analytical processes that detects analytical errors during testing, and ultimately prevent the reporting of inaccurate patient test results
Quality Control
- A program in which the overall activities conducted by the institution are directed toward assuring the quality of the products and services provided
- Focused on recipient (patient) and monitoring of outcomes or indicators of care
- 10 step QA monitoring process (JCAHO)
1. Assign responsibility for QA plan
2. Define scope of patient care
3. Identify important aspects of care
4. Construct indicators
5. Define thresholds for evaluation
6. Collect and organize data
7. Evaluate data
8. Develop corrective action plan
9. Assess action; document improvement
10.Communicate relevant information
Quality Assurance
- Replaced the QA model expanded emphasis on satisfying the needs of the customer
- Focus on the complete process (supplier to customer) and its analytical and troubleshooting methodology
Total Quality Management (TQM) and Continuous Quality Improvement (CQI)
- QA&I incorporates the concepts of quality assurance and TQM/CQI
- QA&I focuses on the success of the organization
in designing and meeting set goals and objectives– “Continuous Performance Improvement” - Steps in improving organizational steps
(JCAHO):
1. Plan the CPI process
2. Design the assessment and monitoring system
3. Measure the performance
4. Assess performance
5. Improve performance - 9 dimensions of performance
1. Efficacy
2. Appropriateness
3. Availability
4. Timeliness
5. Effectiveness
6. Continuity
7. Safety
8. Efficiency
9. Care and Respect
Quality Assessment and Improvement (QA&I)) and Continuous Performance Improvement (CPI)
Major Figures in Quality Management
- Philip Crosby
- W. Edwards Deming
- Joseph Juran
- James O. Westgard
Tools for measurement of quality and performance in the laboratory:
* Statistical techniques
* Graphic and monitoring methods
* Interpretive strategy
* External programs
* Methods that are intended to monitor the delivery of overall services
Quality Monitoring and Assessment Tools
- Arithmetic average for all the data contained in a sample population.
- is a measure of central tendency, it is associated with symmetrical or normal distribution
- Formula: Mean = ∑x
N
Mean ( x̅ )
- A measurement of precision or tendency of the values in each population to cluster, center or scatter around the mean
- A measure of the dispersion of values from the mean. It helps describe the normal curve. A measure of the distribution range. It is the most frequently used measure of variation
- Formula: s = ∑ ( X − X ¯ ) 2 n − 1
Standard Deviation
- Allows a comparison and check on the precision and variability of each method
- Formula: (CV) = (Standard Deviation/Mean) × 100
Coefficient of Variance
Control charts used to plot quality control against previously set limits to determine
Levey-Jennings Chart
- Used to demonstrate and compare performance of a laboratory on paired samples with other laboratories using common control lots or survey material
- Use means and SDs from all participants to prepare a chart on which each laboratory’s results can be marked to show its performance in relationship to the whole group
Youden Plots
- Commonly referred as “Westgard rules”
- Each rule is designed to detect or warn of an impending error or malfunction that may be either halt the reporting of the results until the problem is corrected or signal the need for preventive maintenance
Multirule Analysis
it is used as a rejection or warning rule when one control result exceeds the mean ±2SD; for screening purposes
1₂s
one control result exceeds the mean ± 3SD; it is effective in determining random error
1s
the last 2 control results ( or 2 results from the same run ) exceed either mean ± 2SD; respond most often to systematic errors
2₂s
the last four (or any four) consecutive control results exceed either mean ±1SD; respond to systematic errors
4₁ₓ
the range or difference between the highest and lowest control result within an analytical run exceeds 4SD; respond to random errors or increased imprecision
R₄ₓ
reject when 6 consecutive control measurements fall on one side of the mean
6x
reject when seven control measurements trend in the same direction, i.e., get progressively higher or progressively lower.
7T
reject when 8 consecutive control measurements fall on one side of the mean
8x
reject when 9 consecutive control measurements fall on one side of the mean
9x
ten consecutive results are on the same side of the target mean; systematic error
10x
reject when 12 consecutive control measurements fall on one side of the mean.
12x
reject when 2 out of 3 control measurements exceed the same mean plus 2s or mean minus 2s control limit
2of32s
reject when 3 consecutive control measurements exceed the same mean plus 1s or mean minus 1s control limit.
31s
- Related to accept/ reject and problem/no problem decisions
- An error can be made in either direction
Error
may occur at any time and place within the testing or service process; indicative of imprecision in an analytical process
Random error
occurs in a consistent direction or pattern; problems of inaccuracy show up
Systematic error
Having a set of numbers that do not truly reflect the characteristics of the whole population which may be either circumstantial or intentional
Statistical Bias
Deviations from the symmetrical bell-shaped appearance of a frequency polygon
Skewed Curves
- Marked by a systematic drift in one direction away from the established mean
- Signal the gradual deterioration of procedure components (reagent, standard or instrumentation)
Trend
- Occurs when control values are widely scattered in an unusual and unexplained pattern around the control chart
- Sign of loss of precision
Dispersion
Sudden switch of data points to another area of the control chart away from the previous mean
Shift
