Introduction to quality laboratory management … ASLM...Introduction to quality laboratory management systems, international standards and the GLI Tool Prof. Paul Klatser PhD Royal

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

Amsterdam, The Netherlands www.kit.nl

Would you accept 1% of non-quality ?

Slide from Antoine Pierson


1% of non quality ?

Slide from Antoine Pierson


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


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.


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


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.”


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


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.


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 !!


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.”


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.


Broad consensus

document.

ISO 15189 is not

laboratory

discipline specific.

ISO 15189:

The international

standard for

medical laboratory

quality and

competence


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

Amsterdam, The Netherlands www.kit.nlAmsterdam, The Netherlands www.kit.nl

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

Amsterdam, The Netherlands www.kit.nlAmsterdam, The Netherlands www.kit.nl

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


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


Poor quality sample

Reporting error

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Each system consist of one or more sub systems

Sample

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Sample

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Sample

transport

Sample

reception

Sample

registration

Sample

preparation

Sample

processing

Sample

examination

Recording

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Reporting

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Storage

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Disposal

of sample


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.


GLI Stepwise Process (www.GLIquality.org)


Documents

Introduction to quality laboratory management … ASLM...Introduction to quality laboratory management systems, international standards and the GLI Tool Prof. Paul Klatser PhD Royal