Management functions include planning, organizing, staffing, directing, and controlling. Quality management is essential for laboratories and involves coordinated activities to direct operations regarding quality. A history of quality management innovators from the 1920s to 1980s helped define key concepts like statistical process control, continual improvement, quality tools, quality by requirements, and micro-scale error reduction. International standards now help laboratories implement quality practices that benefit facilities, healthcare systems, and patients.
2. 2
Management:
Is essentially an executive function, the active direction of
human effort. It is the work that a manager seeks to get
results through other people.
Administration and Management
The term "Management" and "Administration" are
used
interchangeably in government and organizations.
3. 3
Management Functions
Function is defined as a broad area of responsibility composed of
many activities aimed at achieving a predetermined objective.
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What is Quality?
Ensuring accuracy, timeliness and
reliability of test results.
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At the end of this activity, you will be able to:
Relate the importance of a laboratory quality
system
Define the principal terms used in the field of
quality
List the essential elements of a laboratory
quality system
Describe the development of quality
principles during the last centuries
Learning Objectives
8. 8
ISO - International Organization for
Standardization
• Quality management standards to help
work more efficiently and reduce product
failures.
• Environmental management standards to
help reduce environmental impacts,
reduce waste and be more sustainable.
• Health and safety standards to help
reduce accidents in the workplace.
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A laboratory occurrence and its
consequences
A 83 year old male was admitted to hospital with fever, weight loss and
cough being investigated for possible tumor. Sputum was reported to be
positive for tuberculosis, but on later review, found to be false positive
culture due to in-laboratory contamination. Further investigation found 14
additional patients with falsely positive TB culture
Delay in correct diagnosis
Unnecessary treatment
Treatment complications.
Pattern of other contaminations discovered
Problem resolution required 6 months of investigation, contacting of more
than 200 patients, many requiring culture and X-Ray re-examination.
Revision of laboratory procedures eradicated the problem.
Laboratory errors cost in time, energy, money
personnel and patient outcomes
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Why the Path of Workflow is essential to
consider in health laboratories
A sample that is damaged or altered as a result
of improper collection, or without consideration
of the effects of transport will always result in an
inaccurate result.
A medical report that is delayed, or lost, or sent
to the wrong clinician, or written in a method that
results in misinterpreted negates all the time and
energy and finances that were spent in
collecting, transporting and performing the
examination properly
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There are many factors that influence whether laboratory
tests will be performed accurately
and in a timely manner.
Competent
staff
Reagents
and equipment
Laboratory
environment
Knowledgeable
staff
Quality
control
Communications
Occurrence
Management
Process
Management
Records
keeping
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Twelve Quality
System Essentials
Quality system
essentials
Set of coordinated
activities that function
as building blocks for
quality management.
Process
Control
(Quality Control
& Specimen
Management)
Purchasing
& Inventory
Assessment
Occurrence
Management
Information
Management
Process
Improvement
Customer
Service
Facilities &
Safety
Organization Personnel Equipment
Documents
& Records
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The Laboratory shall be
legally identifiable
Name
Address
Medical Director
Contact Information
Telephone
Electronic
Path of Workflow
Patients know to
whom to
complain about
inconvenience
Clinician know to
whom to call
about late
reports
Workers know
to whom to
complain about
late salary
cheques
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Quality Management is not new
Walter Shewhart
W. Edwards Deming Joseph Juran
Phillip Crosby
Robert Galvin
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A Short History of Quality Management
Innovator Date Cycle
Walter A Shewhart 1920’s Statistical Process Control
W Edwards Deming 1940’s Continual Improvement
Joseph Juran 1950’s Quality Toolbox
Phillip Crosby 1970’s Quality by Requirement
Robert Galvin 1980’s Micro Scale Error Reduction
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Philip Crosby
1. Quality is defined as conformance to
requirements, not as 'goodness' or 'elegance'.
2. The system for causing quality is prevention,
not appraisal.
3. The performance standard must be Zero
Defects, not "that's close enough".
Absolutes of Quality
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Six Sigma
A modern tool that
blends statistical
process control and
structured project
planning
Total Error Error
Percent
Process
Sigma
1,000,000 100,000 10% 2.78
1,000,000 10,000 1% 3.83
1,000,000 5,000 0.5% 4.08
1,000,000 1,000 0.1% 4.59
1,000,000 500 0.05% 4.79
1,000,000 100 0.01% 5.22
1,000,000 50 0.005% 5.39
1,000,000 10 0.001% 5.76
1,000,000 5 0.0005% 5.92
1,000,000 1 0.0001% 6.25
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ISO and Medical Laboratory Quality
Quality and Competence
Laboratory Safety
Point of Care Testing
Risk Management
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Summary
Quality management is not new.
Quality management grew from the good
works of innovators who defined quality
over a spam of 80 years.
Quality management is applicable for the
medical laboratory as it is for
manufacturing and industry.
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Summary
Through the good works of organizations
including WHO, ISO, CLSI, and others…
Laboratories benefit
Health care benefits
Patients benefit
