Week16 Lmgtreviewer

Workflow analysis
- assimilates all discussed data and transforms them into valuable information. This step can be
done manually or using a commercially available software for part of the analysis. A
comprehensive workstation analysis should identify bottlenecks and highlight areas where
improvements are necessary.
How is this done?

- The easiest way, and one that does not require computer support, is to follow the path of a
specimen or group of specimens through the entire process. This should begin at or near the
bedside to see how physicians are ordering tests and should proceed to specimen acquisition
and delivery to the laboratory.
flow sheet
- which follows the sample from initial order to arrival in the laboratory, should be created. A
separate task force is usually assigned to the pre-laboratory phase because multiple
departments and staff are usually involved; the laboratory often has little or no direct control
over this critical portion of workflow, especially when non-laboratory staff collect samples.
QC (Quality Control)
- Relies heavily on quantitative statistical methods that focus on the final product as defined by
the standards set by the producer.
QA (Quality Assurance)
- Developed out of the limitations of the QC approach and defined quality in health care
institutions by the success of the total organization, not just individual components of the
system in achieving the goals of patient care.
10 Steps in QA Monitoring System
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 and action plan
9. assess action; document improvement
10. communicate relevant information
Quality Assessment and Improvement

- To ensure that quality laboratory services are provided, every laboratory should strive to obtain
modern equipment, to hire well-trained staff, to ensure a well-designed and safe physical
environment, and to create a good management team.
Quality Systems Management
- ultimately dispels the concept of “good enough” and promotes one of “it can always be
done better”.
Standard Approaches to Quality Leadership and Management
1. Total Quality Management (TQM)

• Systems approach that focuses on teams, processes, statistics, and delivery of
services/products that meet or exceed customer expectations.
• Continually look for ways to reduce errors (“defect prevention”) by empowering employees to
assist in solving problems and getting them to understand their integral role within the greater system
(“universal responsibility”)
2. Continuous Quality Improvement (CQI)
• An element of TQM that strives to continually improve practices and not just meet established
quality standards.
3. Six Sigma
• Process improvement program that is a hands-on process with the single mantra of
“improvement”: improved performance, improved quality, improved bottom line, improved
customer satisfaction, improved employee satisfaction.
4. Lean
• Ultimately designed to reduce waste (non-valued activities), which means to reduce cost by
identifying daily work activities that do not directly add to the delivery of laboratory services in the
most efficient or cost-effective ways.
Directly addresess the age-old concept “that’s the way we always did it” and look for ways to improve
the process
MAJOR FIGURES IN QUALITY MANAGEMENT

A. Philip Crosby
• Frequently referred to as Evangelist of quality management
• Preach the need for quality practices in the book Quality is Free.
• He propounded that:
(a) quality is free, poor quality is expensive
(b) do thing right the first time
(c) zero defects is the only legitimate goal of quality program
B. W. Edwards Deming
• Source of most of the concepts and methods contained in the TQM model
• Credited with providing the Japanese with the information and training that brought them to their
position as the world’s leader in production of quality products
C. Joseph Duran
• Established the concept that quality is a continuous improvement process that requires manager’s
active pursuit in reaching and setting goals for improvement.
D. James Westgard
• Applied Shewhart’s multirole system to the evaluation of quality control data in the medical
laboratory.
• Professor at the University of Wisconsin Medical School and associate director of Clinical
Laboratories-Quality assurance with the University of Wisconsin Hospital & Clinics in Madison
Quality Control Statistics

Accuracy and Precision
• Accuracy – nearness or closeness of a result to the actual value of the analyte when performing a
test. (Validity)
• Precision - ability of an analytical method to give repeated results/reproduces a value.
(Reliability/Reproducibility)
Data population
• Used to describe and define the items that
are being studied at a particular time
Quality Control Charts

a. Gaussian Curve,
b. Cumulative Sum Graph (CUSUM),
c. Youden/Twin Plot,
d. Shewhart Levey-Jennings Chart,
e. Westgard Control Rules
METHODS USED FOR SPECIALIZED LABORATORY DATA EVALUATION
Levy Jennings Chart

- are control charts used to plot quality control values against preciously set limits to determine if
the procedure is in or out of control
Youden plot
- are used to demonstrate and compare the performance of a laboratory on paired samples with
other laboratories using common control lots or survey material
Multirule analysis
- commonly referred to in the laboratory as the Westgard rules, has formalized the application
of multirule techniques to the medical laboratory
Westgard Multirule System aka Westgard Rules

- Generally used where 2 levels of control material are analyzed per run
Mean
• Statistical tool used to measure systematic error/accuracy
Standard Deviation
• Statistical tool used to measure precision or the dispersion of values around the mean
Coefficient of Variation
• Statistical tool that allows comparison and check on the precision and variability of each
method
Variations
1. Random error – may occur by chance at any time and place within the testing or service
process
2. Systematic error – error that influences observations consistently in one direction
Random error
- affects the precision of a test (reproducibility). Some things that could cause random errors
are:
a. bubbles in reagents or reagent lines;
b. instrument instability;
c. temperature variations; and
d. operator variability, such as variation in pipetting.
Systematic error
- causes inaccurate results that are consistently low or high. Some things that could cause
systematic errors include:
a. change in reagent lot;
b. change in calibration;
c. assigning the wrong calibrator values;
d. reagents that were improperly prepared or are deteriorating;
e. pipettor maintenance error (not adjusted correctly or misaligned); and/or
f. a deteriorating photometric light source in the instrument.
Errors which can be observed on LJ Chart

1. Trend
- Controls values increasing or decreasing for 6 consecutive runs
- formed by control values that either increase or decrease for six consecutive days
- *main cause is deterioration of reagents
2. Shift
- 6 consecutive control values on same side of mean
- formed by control values that distribute themselves on one side or either side of the mean for
six consecutive days
- *main cause is improper calibration of the instrument
Laboratory Workflow
Three phases of the testing process:
1. Preanalysis
- refers to all the activities that take place before testing, such as test ordering and sample
collection.
2. The analysis
- stage consists of the laboratory activities that actually produce a result, such as running a
sample on an automated analyzer.
3. Postanalysis
- comprises patient reporting and result interpretation. Collectively, all of the interrelated
laboratory steps in the testing process describe its workflow
3 categories of the testing process:

1. Testing phase
2. Role
3. Laboratory technology
Laboratory Design
The guidance and recommendations given as minimum requirements pertaining to laboratories of all
biosafety levels are directed at microorganisms in Risk Groups 1–4.
• Diagnostic and health-care laboratories (public health, clinical or hospital-based) must all be
designed for Biosafety Level 2 or above. As no laboratory has complete control over the specimens it
receives, laboratory workers may be exposed to organisms in higher risk groups than anticipated.

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Week16 Lmgtreviewer

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Workflow analysis

How is this done?

1. assign responsibility for QA plan

Quality Assessment and Improvement

Standard Approaches to Quality Leadership and Management

1. Total Quality Management (TQM)

MAJOR FIGURES IN QUALITY MANAGEMENT

Quality Control Statistics

Quality Control Charts

Levy Jennings Chart

Westgard Multirule System aka Westgard Rules

2. Systematic error – error that influences observations consistently in one direction

Errors which can be observed on LJ Chart

3 categories of the testing process:

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