GLI Stepwise Process towards TB Laboratory Accreditation ... GLI tool dem… · Peru • National TB Reference Laboratory in Cotonou, Benin Background – Idea – Development –

GLI Stepwise Process towards TB Laboratory Accreditation -Demonstration

Tjeerd Datema, MSc.

Royal Tropical Institute, Amsterdam, The Netherlands

Background

Fact: Increase in recognition of the need for quality

management in clinical/diagnostic laboratories

Background – Idea – Development – Optimization – Conclusion

Background

Fact: Growing ambition of

national tuberculosis (TB)

laboratories to implement

quality management systems

complying with international

quality standards

In other words: become accredited


Background

Fact/experience: Difficult to translate the international

quality standard into practice


Background

Fact: Increase in availability of guidance material, aimed

at laboratories in resource limited areas.


Idea

At the start of the TB CARE I (USAID) project funds were

available for developing a tool to guide accreditation of

TB laboratories

Meeting with representatives from GLI, CDC, The UNION, Univ.

of Massachusetts, KNCV Tuberculosis Foundation, Royal

Tropical Institute (KIT)


Idea

Translation ISO 15189 into practice is difficult

+

A lot of guidance material is already available

+

Our own experience in implementing quality management

TB labs need a lot of external assistance for

implementing a quality management system (QMS)

What if we develop a tool that translates the

ISO 15189 into a sequence of practical steps, and

provide links to the already available support

material where possible…


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reception

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preparation

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processing

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examination

Recording

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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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Development

Translation of ISO 15189 into practical

steps

Dividing these steps over 4 phases of

implementation, with each phase having

a specific focus

Phase1

Phase2

Phase3

Phase4


Development

• Phase 1: chosen to keep it simple and easy to achieve; focusing on assuring technical competency of testing performed.

• Phase 2: implement quality control measures and create traceability.

• Phase 3: establish the policy cyclewith proper management, leadershipand planning.

• Phase 4: create continuousimprovement, accumulate evidence.

Phase1

Phase2

Phase3

Phase4


Amsterdam, The Netherlands www.kit.nl
























Optimization

Launch: November 2011, at the UNION conference in Lille, France

Since launch:Use has been increasing to currently 1100 visits per month of which 30% is returning customers.

Experiences of using the tool in practice were received from:• National TB Laboratory in Lima,

Peru• National TB Reference Laboratory

in Cotonou, Benin


Optimization

Improvements planned after 1 year testing in practice:• Activities

• More activities• Adaption of activities• Use of version numbers

• Roadmaps• Checklists


Optimization

Improvements planned after 1 year testing in practice:• Activities• Roadmaps

• Better adapted to practice• More logical• Clearer

• Checklists


Optimization

Improvements planned after 1 year testing in practice:• Activities• Roadmaps• Checklists

• Extended• More user friendly (addition of a function to let the user automatically assemble checklists based on what he/shewants to assess)

• Overall


Optimization

Improvements planned after 1 year testing in practice:• Activities• Roadmaps• Checklists• Overall

• More intuitive• Adaption to ISO 15189:2012• Addition of a page on where the tool is used• Contact form• Forum?• Login?• Translation?


Conclusion

Access the GLI tool at:

www.GLIquality.org

Alternative for those working in a public health laboratory:• World Health Organization Laboratory Quality Stepwise

Implementation tool (WHO LQSI tool)• Launched early 2013• Accessible at WHO website: www.who.int• Leave your email address for information on launch of this

tool


Conclusion

Contributors:

Martin Baker, Stella van Beers, Russell Dacombe, Tjeerd Datema, Armand van Deun, Mirjam Engelberts, Glen Fine, Chris Gilpin, Peter Hessels, Paul Klatser, Linda Oskam, John Ridderhof, Elsie van Schalkwyk, Jerod Scholten, Tom Shinnick, Marina Shulgina

National TB Reference Laboratory, Cotonou, Benin:• Dr. D. Affolabi, Mr. F. Faihun

National TB Laboratory, Lima, Peru:• Mr. D. Coleman

More information/contact: [email protected]

www.GLIquality.orgBackground – Idea – Development – Optimization – Conclusion

GLI Stepwise Process towards TB Laboratory Accreditation ... GLI tool dem… · Peru • National TB Reference Laboratory in Cotonou, Benin Background – Idea – Development –

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