Introduction to quality laboratory management systems, international standards and the GLI ToolProf. Paul Klatser PhDRoyal Tropical Institute (KIT)/University of AmsterdamKIT Biomedical Research*Amsterdam, The Netherlands
*ISO15189 accredited
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Would you accept 1% of non-quality ?
Slide from Antoine Pierson
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Quality assurance through guilds* in the Middle- Ages (up to 18th century)
Protection of the worker and of the consumer
Only a fully qualified master could become a member of the guild.
Goods and services were inspected
Members of guilds were expected to undertake long apprenticeships
*A guild is a society of persons united by a
particular aim or occupation (craftsmen). The Governors of
a Guild of painters
in 1675
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The Sampling Officials (Dutch: De Staalmeesters) -
Syndics of the Drapers’ Guild, 1662
Quality control (inspection): they controlled the quality of
dyed ' laken' cloth, a fine woollen fabric.
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Development of standards for quality and of thinking about quality requirements
1) Standards developed for products,
procurement and suppliers (1940’- 1950’
– 1960’)
Forerunners: US military industry,
Japanese manufactory industry and
Aeronautics and Space program
2) Thinking about quality management
developed
• Phil Crosby, 1926 - 2001
• W.Edwards Deming, 1900 -1993
• Joseph M. Juran, 1904 - 2008
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Edward Deming
"It is not enough to just do your best or work hard. You must know
what to work on."-
Quality is everyone's responsibility.”
“The emphasis should be on why we do a
job.”
“Does experience help? NO! Not if we are doing the wrong
things.”
“If you can't describe
what you are doing as a process, you don't know what you're doing.”
Our customers should take joy in our
products and services.”
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Levels of quality implementation
5) Quality management – coordinated activities to direct and control an organization with regard to quality activities and techniques to achieve and maintain the quality of a product, process or service.
4) Quality system is the organizational structure, resources, processes and procedures
3) Quality assurance is the prevention of quality problems through planned and systematic activities around processes.
2) Quality control steps taken during the generation of a product or service to ensure product/service quality.
1) Inspection – determining whether product or service has the required quality – required specified standards
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Quality of labs is essential in health laboratories and health care systems
• Reliable results by laboratories improve the decision making capacity of the clinicians/health workers as well as public health authorities.
• The consequences of poor quality are serious: inappropriate treatment, investigation and responses.
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Quality is most of all
The right test result, at the right time,
on the right specimen, from the right patient, with result interpretation
based on correct reference data, and at the right price.
Summarized:
Doing the right things right !!
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Doing the right things right?
• What are the “right things” in a laboratory?
• How do you know if you do them right?
Quality Management Standards may help:
A standard is a document that provides requirements,
specifications, guidelines or characteristics that can be
used consistently to ensure that materials, products,
processes and services are fit for their purpose
(definition by ISO).
“The emphasis
should be on
why we do a
job.”
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Standards Organizations
ISOInternational Organization for
Standardization
Guidance for quality in manufacturing and service industries
Broad applicability; used by many kinds of organizations
Uses consensus process in developing standards
A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.
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Broad consensus
document.
ISO 15189 is not
laboratory
discipline specific.
ISO 15189:
The international
standard for
medical laboratory
quality and
competence
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Definitions
Certification (ISO/IEC 17000)
• Procedure by which a third party gives written assurance
that a product, process or service conforms to specific
requirements.
Accreditation (ISO 15189)
• Procedure by which an authoritative body gives formal
recognition that a body or person is competent to care out
specific tasks.
Licensure (Wikipedia)
• Granting of ability to practice provided most often by a
local governmental agency, usually based on
demonstrated knowledge, training and skills.
Accreditation
Provided by an accreditation body
• South African National Accreditation System (SANAS)• Organismo Argentino de Acreditacion (OAA)• Dutch Accreditation Council (RvA)• Etc.
• They all have to be accredited themselves to ISO 17021Conformity assessment -- Requirements for bodies providing audit and certification of management systems
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Goal of a QM System
For the laboratory:
• To operate efficiently and effectively, meeting regulatory requirements
• To be managed with the interests of the patients
• To ensure that everyone understands who is responsible for doing what, when, why, where and how
• To continually strive for improvement
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Stated simply
• Say what you do (document)
• Do what you say
• State of the art (professionally)
• Standardize, standardize, standardize
• Measure and monitor those things that are important to your customer
• Focus on the process
• Assess
ISO15189 specifies requirements for each step“ Specific instructions for proper collection of samples shall be documented and implemented by laboratory management and made available to those responsible for sample collection (ISO:5.4.2)”
shall
shall
shallshall
shall
shallshall
shall
shall
shall
shall shall
…but not how!
STANDARD
STANDARD CRITERIAProper collection Outside or otherwise in area without risk
of infection for others
Patient has received the right
instructions on how best to provide
sputum
Sputum quality Volume must be at least 1 ml, with
purulent parts and not only saliva
Sputum container Clean
Mulit-thread screw cap
Wide mouth
Clear and break resistent plastic
Labeling container Clearly , legible labeled with patient' s
name, date and time of collection
Lable on the container, not on the lid
Samples are properly collected, of good quality and stored in
good, correctly labeled containers
Sample collection
The chain is as strong as the weakest link
Sample
request
Sample
collection
Sample
transport
Sample
reception
Sample
registration
Sample
preparation
Sample
processing
Sample
examination
Recording
of results
Reporting
of results
Storage
of sample
Disposal
of sample
POST -ANALYTICALPRE-ANALYTICAL ANALYTICAL
Sample
request
Sample
collection
Sample
transport
Sample
reception
Sample
registration
Sample
preparation
Sample
processing
Sample
examination
Recording
of results
Reporting
of results
Storage
of sample
Disposal
of sample
POST -ANALYTICALPRE-ANALYTICAL ANALYTICAL
Sample
request
Sample
collection
Sample
transport
Sample
reception
Sample
registration
Sample
preparation
Sample
processing
Sample
examination
Recording
of results
Reporting
of results
Storage
of sample
Disposal
of sample
POST -ANALYTICALPRE-ANALYTICAL ANALYTICAL
Poor quality sample
Reporting error
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Each system consist of one or more sub systems
Sample
request
Sample
collection
Sample
transport
Sample
reception
Sample
registration
Sample
preparation
Sample
processing
Sample
examination
Recording
of results
Reporting
of results
Storage
of sample
Disposal
of sample
POST -ANALYTICALPRE-ANALYTICAL ANALYTICAL
RESOURCES THE WORK
MEASUREMENT
AND
IMPROVEMENT
Personnel Safety Assessments
Equipment Process ControlOccurrence
Management
Purchasing &
Inventory
Document &
RecordsCustomer service
Facilities &
Safety
Information
management
Process
improvement
ORGANIZATION and MANAGEMENT
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Links to additional materials
to preventthe laboratory from reinventing the wheel:
• Guidelines on specific topics (e.g. EQA)• Course materials (LQMS + SLMTA)• Document templates (KIT, GLI)• Procurement software (GLI)
Many documents and tools available
• Roadmaps, guidelines, SOPs formats, training tool kits, roadmaps, checklists, etc.
BUT:
• Operational translation of guidelines is missing: where to start and how to proceed?
• Little attention to management aspects. • Shortage of harmonization/standardization.• Not always addressing TB specific needs.
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