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Module 3

• Quality Management System

• defined as “coordinated activities to direct and control an organization with regard to quality”
• Quality Control (QC)
• refers specifically to the activities directed toward monitoring the individual elements of care
• Quality Assurance (QA)
• a program in which the overall activities conducted by the institution are directed toward
assuring the quality of the products and services provided
• Total Quality Management (TQM)
• 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
• Quality Assessment and Improvement (QA&I)
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• A quality management program that focuses on the success of the organization in designing
and achieving its set goals and objectives
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• 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

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• 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
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10. Communicate relevant information

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• 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

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• QA&I incorporates the concepts of quality • 9 dimensions of performance

assurance and TQM/CQI 1. Efficacy
• QA&I focuses on the success of the organization 2. Appropriateness
in designing and meeting set goals and 3. Availability
objectives  “Continuous Performance
4. Timeliness
Improvement”
5. Effectiveness
• Steps in improving organizational steps
6. Continuity
(JCAHO):
7. Safety
1. Plan the CPI process
8. Efficiency
2. Design the assessment and monitoring
system 9. Care and Respect
3. Measure the performance
4. Assess performance
5. Improve performance
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• Philip Crosby
• W. Edwards Deming
• Joseph Juran
• James O. Westgard

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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

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• Accuracy vs Precision

Triglycerides Standard= 200mg/dL

Run 1 169
Run 2 167
Run 3 170
Run 4 168
Run 5 169

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• Data Population vs Population Sample

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• Gaussian Distribution

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• Percentage and Probability

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• Mean ( x̅ )
• 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
• Standard Deviation
• 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:

• Coefficient of Variance
• Allows a comparison and check on the precision and variability of each method
• Formula:
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• Data alone have no particular interpretive value

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• First task: arrange and present data in a manner that facilities further analysis-”orderly
array of data”
• Once results are arrayed in an orderly manner, results can be presented in an informative
format (graph, chart or pictorial display)
• Basic Statistical Graphs
• Gaussian Distribution Displays

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• Circle or Pie Charts

Patient Base of Quality Laboratory

12%

8%
5%

5%

65% 3%
2%

ER Rooms Outpatients Satellite Physician's office

Service Contracts Other Sources Inpatients 16

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• Bar Graphs

Patient Base of Quality Laboratory

70

60

50

40

30

20

10

0
Inpatients ER Rooms Outpatients Satellite Physician Service Other Sources
Office Contracts 17

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• Line graphs

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• Histogram
• Frequency polygon

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• Flow Charts

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• Control Charts

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• Pareto Charts

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• Cause-and-Effect Diagrams

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• Run Charts
• Scatter Diagram
• Story Boards

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• Levey-Jennings Chart
• Control charts used to plot quality control against previously set limits to determine

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• Youden Plots
• 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

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• Multirule Analysis
• 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

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• 1₂s -it is used as a rejection or warning rule when one control result exceeds the mean
±2SD; for screening purposes

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• 1₃s -one control result exceeds the mean ± 3SD; it is effective in determining random
error

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• 2₂s -the last 2 control results ( or 2 results from the same run ) exceed either mean ±
2SD; respond most often to systematic errors

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• 4₁ₓ - the last four (or any four) consecutive control results exceed either mean ±1SD;
respond to systematic errors

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• R₄ₓ - the range or difference between the highest and lowest control result within an
analytical run exceeds 4SD; respond to random errors or increased imprecision

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• 6x – reject when 6 consecutive control measurements fall on one side of the mean

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• 7T – reject when seven control measurements trend in the same direction, i.e., get
progressively higher or progressively lower.

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• 8x - reject when 8 consecutive control measurements fall on one side of the mean.

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• 9x - reject when 9 consecutive control measurements fall on one side of the mean.

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• 10x – ten consecutive results are on the same side of the target mean; systematic error

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• 12x – reject when 12 consecutive control measurements fall on one side of the mean.

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• 2of32s – reject when 2 out of 3 control measurements exceed the same mean plus 2s or
mean minus 2s control limit

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• 31s - reject when 3 consecutive control measurements exceed the same mean plus 1s or
mean minus 1s control limit.

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• Error
• Related to accept/ reject and problem/no problem decisions
• An error can be made in either direction
• 2 types:
• Random error- may occur at any time and place within the testing or service
process; indicative of imprecision in an analytical process
• Systematic error- occurs in a consistent direction or pattern; problems of
inaccuracy show up

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• Statistical Bias
• Having a set of numbers that do not truly reflect the characteristics of the whole
population which may be either circumstantial or intentional

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• Skewed Curves
• Deviations from the symmetrical bell-shaped appearance of a frequency polygon

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• Trend
• Marked by a systematic drift in one direction away from the established mean
• Signal the gradual deterioration of procedure components (reagent, standard or
instrumentation)

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• Dispersion
• Occurs when control values are widely scattered in an unusual and unexplained pattern around
the control chart
• Sign of loss of precision

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• Shift
• Sudden switch of data points to another area of the control chart away from the previous mean

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2 types for review

purposes

Licensure and
accreditation
Proficiency surveys
programs/Laboratory
Inspection 47

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Unknown samples must

be tested by the
Series of unknown
laboratorians who
samples are sent to the The results are submitted
regularly perform
laboratory to from the to the program provider,
analysis of patient
reference laboratory or preferably as soon as
specimens using the
authorized program every analysis is done
same reagents and
provider
equipment for actual
patient specimen

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Utilization
Review

Peer Review
Organization
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• Critical-Care Pathways
• A hospital-wide quality care management program that places emphasis on the
outcomes of treatment received by the patient as the definition of quality
• Emphasis on the outcomes of treatment received by the patient as the definition of
quality
• Incorporates all the resources of the health care system into delivery of an exact
series of interventions or treatments that are to be received by the patient in a
designated time period in response to specific symptoms

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The Philosophy
or Attitude of its
People

AREAS

The Actual
Quality
Assessment The Operational
and Monitoring Systems 51
Program in
Place

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QC/MBO

QA&I/ CPI QA

TQM/CQI 52

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• Ongoing activities that can be defined directly as part of quality management programs include:

Policy and
Preventive Procedure Manual Quality Control
Maintenance (PM) Writing and Functions
Review

Staff Orientation,
Problem solving
Continuing Participation in
and
Education and Proficiency Testing
troubleshooting
Development

Laboratory
Inspection,
Accreditation and
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Licensure Process

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